Pediatric Pharmacy Quality Management System

A comprehensive QMS template designed for pediatric pharmacy operations including hospital pediatric services, neonatal intensive care, pediatric oncology, and specialized pediatric compounding.

👶 Designed For

• Pediatric Hospital Pharmacies - Inpatient and outpatient pediatric services
• Neonatal Intensive Care (NICU) - Specialized neonatal medication preparation
• Pediatric Oncology Pharmacies - Chemotherapy preparation for children
• Pediatric Compounding Pharmacies - Age-appropriate formulations and flavoring
• Children's Hospital Central Pharmacies - Comprehensive pediatric medication services
• Pediatric Specialty Clinics - Outpatient pediatric medication management
• Pediatric Home Infusion - Home-based pediatric therapy

📋 Regulatory Framework

This template supports compliance with:

• State Board of Pharmacy regulations for pediatric services
• DEA (Drug Enforcement Administration) requirements for controlled substances in minors
• FDA regulations for pediatric drug handling and off-label use
• USP <795> - Non-Sterile Compounding (pediatric formulations)
• USP <797> - Sterile Compounding (NICU, TPN, chemotherapy)
• USP <800> - Hazardous Drug Handling (pediatric oncology)
• Joint Commission - Pediatric medication safety standards
• ISMP (Institute for Safe Medication Practices) - Pediatric medication safety guidelines
• AAP (American Academy of Pediatrics) - Pediatric pharmacy practice standards
• PPAG (Pediatric Pharmacy Association) - Best practices
• HIPAA - Patient privacy and data protection for minors
• ACIP - Vaccine storage and administration guidelines

Repository Structure

├── SOPs/
│   ├── Dosing-Verification/    # Weight/BSA-based dosing verification
│   ├── Compounding/            # Pediatric formulations & flavoring
│   ├── Chemotherapy/           # Pediatric oncology preparations
│   ├── Patient-Safety/         # Pediatric-specific error prevention
│   ├── Controlled-Substances/  # DEA compliance for minors
│   ├── Inventory/              # Pediatric drug procurement
│   └── General/                # General pharmacy operations
├── Forms/
│   ├── Dose-Calculation/       # Weight/BSA dosing worksheets
│   ├── Compounding-Records/    # Pediatric formulation logs
│   ├── Temperature-Logs/       # Vaccine & medication storage
│   ├── Controlled-Substance/   # DEA forms for pediatric patients
│   └── Training/               # Competency assessments
├── Policies/                   # Pediatric pharmacy policies
├── Work-Instructions/          # Step-by-step procedures
└── Templates/                  # Document templates

🤖 AI-Powered Assistance

This repository includes AtomicAI, your pediatric pharmacy QMS assistant. Mention @atomicai in any issue or pull request to:

• Draft pediatric pharmacy SOPs following best practices
• Create weight-based and BSA-based dosing protocols
• Generate pediatric compounding formulation records
• Develop neonatal medication safety procedures
• Create pediatric chemotherapy preparation protocols
• Review documents for pediatric medication safety compliance

Example Prompts

• "@atomicai create an SOP for neonatal TPN compounding per USP 797"
• "@atomicai draft a weight-based dosing verification procedure"
• "@atomicai write a policy for pediatric high-alert medications"
• "@atomicai create a pediatric chemotherapy preparation checklist"
• "@atomicai develop an off-label medication documentation form"
• "@atomicai create a neonatal medication error prevention protocol"

Getting Started

1. Customize Policies - Update policies in /Policies for your pediatric service
2. Adapt SOPs - Modify SOPs to match your pediatric workflow
3. Set Up Dosing Tools - Configure weight/BSA-based dosing verification forms
4. Train Staff - Use pediatric-specific competency forms
5. Establish Safety Protocols - Implement high-alert medication procedures for children

Key Documents to Create First

1. Weight-Based Dosing SOP - Core pediatric dosing verification workflow
2. Neonatal Medication Safety Policy - Foundation for NICU safety
3. Pediatric High-Alert Medications - Critical safety protocols
4. Compounding for Pediatrics SOP - Age-appropriate formulations
5. Off-Label Use Documentation - Required for pediatric practice
6. Chemotherapy Preparation SOP - If providing pediatric oncology services
7. TPN Compounding SOP - If providing neonatal/pediatric nutrition support

Special Considerations for Pediatric Pharmacy

Dosing Calculations

• Weight-based dosing (mg/kg)
• Body surface area (BSA) calculations
• Age-appropriate dose ranges
• Maximum dose verification
• Renal/hepatic adjustments for children

Compounding

• Suspension preparation from tablets/capsules
• Flavoring for palatability
• Low-concentration preparations
• Unit-dose packaging for accuracy
• Stability considerations for pediatric formulations

Safety

• Double-check verification systems
• High-alert medications (concentrated electrolytes, insulin, etc.)
• Look-alike/sound-alike medications in pediatrics
• Calculation error prevention
• Transition of care (NICU to pediatric to adult)

Documentation

• Off-label use (>50% of pediatric medications)
• Age/weight at time of dispensing
• Parent/guardian counseling
• Developmental appropriateness

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This template is maintained by AtomicQMS. For questions, open an issue in this repository.