85 lines
3.5 KiB
Markdown
85 lines
3.5 KiB
Markdown
# Pharmacy Quality Management System
|
|
|
|
A comprehensive QMS template designed for pharmacy operations including retail, hospital, compounding, and specialty pharmacies.
|
|
|
|
## 💊 Designed For
|
|
|
|
- **Retail Pharmacies** - Community and chain pharmacies
|
|
- **Hospital Pharmacies** - Inpatient and outpatient pharmacy services
|
|
- **Compounding Pharmacies** - Sterile and non-sterile compounding
|
|
- **Specialty Pharmacies** - High-cost and complex medication management
|
|
- **Long-Term Care Pharmacies** - Nursing home and assisted living facilities
|
|
- **Mail Order Pharmacies** - Central fill and mail-order operations
|
|
- **Nuclear Pharmacies** - Radiopharmaceutical preparation
|
|
|
|
## 📋 Regulatory Framework
|
|
|
|
This template supports compliance with:
|
|
|
|
- **State Board of Pharmacy** regulations
|
|
- **DEA** (Drug Enforcement Administration) requirements
|
|
- **FDA** regulations for drug handling
|
|
- **USP <795>** - Non-Sterile Compounding
|
|
- **USP <797>** - Sterile Compounding
|
|
- **USP <800>** - Hazardous Drug Handling
|
|
- **USP <825>** - Radiopharmaceuticals
|
|
- **HIPAA** - Patient privacy and data protection
|
|
- **Joint Commission** - Hospital pharmacy standards
|
|
- **ACHC/URAC** - Specialty pharmacy accreditation
|
|
|
|
## Repository Structure
|
|
|
|
```
|
|
├── SOPs/
|
|
│ ├── Dispensing/ # Prescription processing & dispensing
|
|
│ ├── Compounding/ # Sterile & non-sterile compounding
|
|
│ ├── Controlled-Substances/# DEA compliance & C-II handling
|
|
│ ├── Inventory/ # Drug procurement & management
|
|
│ ├── Patient-Safety/ # Error prevention & reporting
|
|
│ └── General/ # General pharmacy operations
|
|
├── Forms/
|
|
│ ├── Compounding-Logs/ # Master formulation & batch records
|
|
│ ├── Temperature-Logs/ # Refrigerator & freezer monitoring
|
|
│ ├── Controlled-Substance/ # DEA forms & perpetual inventory
|
|
│ └── Training/ # Competency assessments
|
|
├── Policies/ # Pharmacy policies
|
|
├── Work-Instructions/ # Step-by-step procedures
|
|
└── Templates/ # Document templates
|
|
```
|
|
|
|
## 🤖 AI-Powered Assistance
|
|
|
|
This repository includes **AtomicAI**, your pharmacy QMS assistant. Mention `@atomicai` in any issue or pull request to:
|
|
|
|
- Draft pharmacy SOPs following USP guidelines
|
|
- Create compounding formulation records
|
|
- Generate controlled substance procedures
|
|
- Develop patient counseling protocols
|
|
- Review documents for regulatory compliance
|
|
|
|
### Example Prompts
|
|
|
|
- "@atomicai create an SOP for sterile compounding garbing procedures per USP 797"
|
|
- "@atomicai draft a controlled substance discrepancy investigation form"
|
|
- "@atomicai write a policy for medication error reporting"
|
|
- "@atomicai create a temperature excursion response procedure"
|
|
|
|
## Getting Started
|
|
|
|
1. **Customize Policies** - Update policies in `/Policies` for your pharmacy type
|
|
2. **Adapt SOPs** - Modify SOPs to match your workflow and state requirements
|
|
3. **Set Up Logs** - Configure forms for your compounding and inventory needs
|
|
4. **Train Staff** - Use training forms to document competencies
|
|
|
|
## Key Documents to Create First
|
|
|
|
1. **Dispensing SOP** - Core prescription processing workflow
|
|
2. **Error Reporting Policy** - Patient safety foundation
|
|
3. **Controlled Substance Policy** - DEA compliance essential
|
|
4. **Compounding SOPs** - If applicable to your practice
|
|
5. **HIPAA Policy** - Patient privacy requirements
|
|
|
|
---
|
|
|
|
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
|