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Pediatric Pharmacy Quality Policy

Document ID POL-001
Title Pediatric Pharmacy Quality Policy
Revision 1.0
Effective Date [DATE]
Author [AUTHOR]
Approved By [APPROVER]

1. Policy Statement

[ORGANIZATION NAME] Pediatric Pharmacy is committed to providing safe, effective, and developmentally appropriate pharmaceutical care for infants, children, and adolescents. We strive for excellence in pediatric medication therapy through evidence-based practices, continuous quality improvement, and unwavering commitment to medication safety for our youngest patients.

2. Quality Objectives

Our pediatric pharmacy commits to:

  1. Pediatric Patient Safety: Ensuring accurate dosing calculations and age-appropriate formulations for all pediatric patients
  2. Medication Error Prevention: Implementing multiple verification systems to prevent calculation errors, wrong doses, and medication mix-ups
  3. Regulatory Compliance: Maintaining compliance with all applicable pharmacy regulations, USP standards, and pediatric-specific guidelines
  4. Clinical Excellence: Providing evidence-based pharmaceutical care appropriate to each developmental stage (neonate, infant, child, adolescent)
  5. Family-Centered Care: Engaging parents, guardians, and age-appropriate patients in medication education and counseling
  6. Continuous Improvement: Continually improving pediatric pharmacy processes through data analysis, error reporting, and quality initiatives
  7. Staff Competency: Ensuring all pharmacy personnel are trained and competent in pediatric-specific calculations, compounding, and safety protocols
  8. Off-Label Use Management: Documenting and monitoring off-label medication use with appropriate clinical justification

3. Pediatric-Specific Commitments

Top management and the pharmacy leadership demonstrate commitment to pediatric pharmaceutical care by:

  • Ensuring weight-based and BSA-based dosing verification for all pediatric orders
  • Implementing independent double-check systems for high-alert medications in children
  • Providing access to pediatric dosing references and calculation tools
  • Maintaining competency in pediatric compounding, including flavoring and age-appropriate formulations
  • Ensuring proper handling of neonatal medications, including dilutions and concentrations
  • Supporting pediatric medication safety initiatives and error prevention programs
  • Maintaining compliance with USP <795>, <797>, and <800> for pediatric preparations
  • Documenting and reviewing all pediatric medication errors and near-misses
  • Ensuring appropriate transition of care protocols from neonatal to pediatric to adult services

4. Scope

This policy applies to all personnel involved in:

  • Pediatric medication order verification
  • Dosing calculation and verification
  • Pediatric compounding (sterile and non-sterile)
  • Neonatal medication preparation
  • Pediatric chemotherapy preparation
  • TPN compounding for neonates and children
  • Vaccine storage and administration
  • Medication counseling for pediatric patients and families
  • Controlled substance management for minors

This policy covers patients from birth through 18 years of age (or up to 21 years as defined by institutional policy).

5. High-Alert Medications in Pediatrics

We recognize that certain medications pose heightened risk in pediatric populations and require additional safeguards:

  • Concentrated electrolytes (potassium, sodium chloride >0.9%, calcium)
  • Insulin and hypoglycemic agents
  • Opioids and sedatives in neonates and infants
  • Chemotherapy agents
  • Anticoagulants (heparin, enoxaparin)
  • Neuromuscular blocking agents
  • IV medications requiring dilution or dose calculation
  • Medications with narrow therapeutic indices in children

6. Dosing Safety

All pediatric medication orders must include:

  • Patient's current weight (in kg)
  • Patient's age (or gestational age for neonates)
  • Indication for use (especially for off-label medications)
  • Dose expressed in appropriate units (mg/kg, mg/m², etc.)
  • Maximum dose limits verified
  • Calculation verification by independent pharmacist

7. Communication

This policy shall be:

  • Communicated to all pharmacy personnel and relevant clinical staff
  • Reviewed annually and updated as pediatric pharmacy practice standards evolve
  • Available to parents and guardians upon request
  • Integrated into new employee orientation and ongoing training

8. Quality Monitoring

Quality indicators for pediatric pharmacy include:

  • Pediatric medication error rates (by category)
  • Dosing calculation errors prevented
  • Compounding accuracy and sterility testing results
  • Time to preparation for stat neonatal/pediatric orders
  • Off-label use documentation compliance
  • Parent/guardian counseling completion rates
  • Staff competency assessment results

Revision History

Rev Date Description Author
1.0 [DATE] Initial release [AUTHOR]