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
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. 7

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
Often times, people will turn to investigational studies when they have no other options for treating a disease state. 11

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 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
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 12

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 Ordering a dose in volume
Wrong Right
.1 mg 0.1 mg
1.0 mg 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
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 for Safe 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: (right) (wrong)
Do not use trailing zeros: (right) (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
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 44

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

51. 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

52. 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

53. 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

54. Additional Information on Automation Available in Slide Deck for Chapter 15

55. 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.