Preventing Medication Errors in Pediatric and Neonatal Patients

1. Preventing Medication Errors in Pediatric and Neonatal Patients

2. 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

3. 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 .

4. 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.

5. 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

6. 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)

7. 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

8. 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

9. 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

10. Lack of Pediatric Formulations • Pitfalls of altering adult formulations • Insufficient data to support practice • Expiration dating of compounded formulation • Unknown bioavailability • Extemporaneous compounding errors

11. 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

12. 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 ActPediatric 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 mustinclude a pediatric data assessment • Provided 6-month exclusivity extension • Provided funding for research of “orphan” therapies

13. 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

14. Adult Versus Pediatric Formulations • Different concentrations • Different volumes • Should be stored in separate locations to avoid errors • Within the pharmacy • On nursing units

15. 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

16. 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

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

18. 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

19. 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

20. Calculation Errors • Misuse of decimals WrongRight .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

21. 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

22. 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)

23. 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

24. 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

25. 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 forSafe Medication Practices. Safety briefs. ISMP Medication Safety Alert! February 26, 1997;2:1.

26. 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

27. 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

28. 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

29. 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

30. 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

31. Strategies for Medication Error Reduction

32. 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.

33. 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

34. 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

35. Know Your Own Height and Weight • Provides a frame of reference • Know your height in centimeters • Know your weight in kilograms

36. 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 weight-based dosing • Require independent double check of dosing calculations

37. 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

38. 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: 0.1 (right) .1 (wrong) • Do not use trailing zeros: 1 (right) 1.0 (wrong)

39. 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.

40. 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

41. 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

42. 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

43. 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

44. 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

45. Section of Broselow Tape

46. 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

47. 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

48. 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

49. 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

50. Automation • Automated Dispensing Cabinets (ADC) • Bar Code Point of Care (BPOC) • Computerized Prescriber Order Entry (CPOE) • “Smart” Infusion Pumps