Download Preventing Medication Errors in Pediatric and Neonatal

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.