# 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.*