124 lines
5.6 KiB
Markdown
124 lines
5.6 KiB
Markdown
# Pediatric Pharmacy Quality Management System
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A comprehensive QMS template designed for pediatric pharmacy operations including hospital pediatric services, neonatal intensive care, pediatric oncology, and specialized pediatric compounding.
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## 👶 Designed For
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- **Pediatric Hospital Pharmacies** - Inpatient and outpatient pediatric services
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- **Neonatal Intensive Care (NICU)** - Specialized neonatal medication preparation
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- **Pediatric Oncology Pharmacies** - Chemotherapy preparation for children
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- **Pediatric Compounding Pharmacies** - Age-appropriate formulations and flavoring
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- **Children's Hospital Central Pharmacies** - Comprehensive pediatric medication services
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- **Pediatric Specialty Clinics** - Outpatient pediatric medication management
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- **Pediatric Home Infusion** - Home-based pediatric therapy
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## 📋 Regulatory Framework
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This template supports compliance with:
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- **State Board of Pharmacy** regulations for pediatric services
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- **DEA** (Drug Enforcement Administration) requirements for controlled substances in minors
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- **FDA** regulations for pediatric drug handling and off-label use
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- **USP <795>** - Non-Sterile Compounding (pediatric formulations)
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- **USP <797>** - Sterile Compounding (NICU, TPN, chemotherapy)
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- **USP <800>** - Hazardous Drug Handling (pediatric oncology)
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- **Joint Commission** - Pediatric medication safety standards
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- **ISMP** (Institute for Safe Medication Practices) - Pediatric medication safety guidelines
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- **AAP** (American Academy of Pediatrics) - Pediatric pharmacy practice standards
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- **PPAG** (Pediatric Pharmacy Association) - Best practices
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- **HIPAA** - Patient privacy and data protection for minors
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- **ACIP** - Vaccine storage and administration guidelines
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## Repository Structure
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```
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├── SOPs/
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│ ├── Dosing-Verification/ # Weight/BSA-based dosing verification
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│ ├── Compounding/ # Pediatric formulations & flavoring
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│ ├── Chemotherapy/ # Pediatric oncology preparations
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│ ├── Patient-Safety/ # Pediatric-specific error prevention
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│ ├── Controlled-Substances/ # DEA compliance for minors
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│ ├── Inventory/ # Pediatric drug procurement
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│ └── General/ # General pharmacy operations
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├── Forms/
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│ ├── Dose-Calculation/ # Weight/BSA dosing worksheets
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│ ├── Compounding-Records/ # Pediatric formulation logs
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│ ├── Temperature-Logs/ # Vaccine & medication storage
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│ ├── Controlled-Substance/ # DEA forms for pediatric patients
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│ └── Training/ # Competency assessments
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├── Policies/ # Pediatric pharmacy policies
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├── Work-Instructions/ # Step-by-step procedures
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└── Templates/ # Document templates
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```
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## 🤖 AI-Powered Assistance
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This repository includes **AtomicAI**, your pediatric pharmacy QMS assistant. Mention `@atomicai` in any issue or pull request to:
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- Draft pediatric pharmacy SOPs following best practices
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- Create weight-based and BSA-based dosing protocols
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- Generate pediatric compounding formulation records
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- Develop neonatal medication safety procedures
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- Create pediatric chemotherapy preparation protocols
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- Review documents for pediatric medication safety compliance
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### Example Prompts
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- "@atomicai create an SOP for neonatal TPN compounding per USP 797"
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- "@atomicai draft a weight-based dosing verification procedure"
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- "@atomicai write a policy for pediatric high-alert medications"
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- "@atomicai create a pediatric chemotherapy preparation checklist"
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- "@atomicai develop an off-label medication documentation form"
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- "@atomicai create a neonatal medication error prevention protocol"
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## Getting Started
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1. **Customize Policies** - Update policies in `/Policies` for your pediatric service
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2. **Adapt SOPs** - Modify SOPs to match your pediatric workflow
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3. **Set Up Dosing Tools** - Configure weight/BSA-based dosing verification forms
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4. **Train Staff** - Use pediatric-specific competency forms
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5. **Establish Safety Protocols** - Implement high-alert medication procedures for children
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## Key Documents to Create First
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1. **Weight-Based Dosing SOP** - Core pediatric dosing verification workflow
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2. **Neonatal Medication Safety Policy** - Foundation for NICU safety
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3. **Pediatric High-Alert Medications** - Critical safety protocols
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4. **Compounding for Pediatrics SOP** - Age-appropriate formulations
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5. **Off-Label Use Documentation** - Required for pediatric practice
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6. **Chemotherapy Preparation SOP** - If providing pediatric oncology services
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7. **TPN Compounding SOP** - If providing neonatal/pediatric nutrition support
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## Special Considerations for Pediatric Pharmacy
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### Dosing Calculations
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- Weight-based dosing (mg/kg)
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- Body surface area (BSA) calculations
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- Age-appropriate dose ranges
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- Maximum dose verification
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- Renal/hepatic adjustments for children
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### Compounding
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- Suspension preparation from tablets/capsules
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- Flavoring for palatability
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- Low-concentration preparations
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- Unit-dose packaging for accuracy
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- Stability considerations for pediatric formulations
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### Safety
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- Double-check verification systems
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- High-alert medications (concentrated electrolytes, insulin, etc.)
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- Look-alike/sound-alike medications in pediatrics
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- Calculation error prevention
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- Transition of care (NICU to pediatric to adult)
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### Documentation
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- Off-label use (>50% of pediatric medications)
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- Age/weight at time of dispensing
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- Parent/guardian counseling
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- Developmental appropriateness
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---
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*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
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