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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):7229.
Kaushal R, et al. JAMA. 2001;285:211420.

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 doesnt fit all
Preterm neonates (<36 weeks gestation)
Full-term neonates (birth to 30 days)
Infants (112 months)
Toddlers (14 years)
Children (512 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 Childrens 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 1015 mg/kg/dose q 68 hr
Ampicillin 100200 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):7229.

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


Patients 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 (wrong)

1 (right)

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; 11.111.16.

Reduction of Prescribing Errors


Write directly into patients 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 childs length, tape estimates childs 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 surgeons
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 physicians 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; 11.111.16.
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.