# Pediatric Pharmacy Quality Policy

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

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## 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

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## Revision History

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