The Pharmacy Risk Assessment Template is a critical document designed to help Australian pharmacies maintain compliance with regulatory requirements while ensuring safe and effective operations. This template should be used when conducting initial risk assessments, annual reviews, or when significant changes occur in pharmacy operations. It encompasses all aspects of pharmacy practice including medication management, controlled substances handling, staff safety, customer protection, and data security. The document aligns with Australian healthcare regulations, including requirements from the Pharmacy Board of Australia, state/territory health departments, and relevant professional standards. It provides a systematic approach to identifying potential risks, evaluating their impact, and implementing appropriate control measures, while maintaining detailed documentation for compliance purposes.
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1. 1. Introduction: Purpose of the risk assessment and scope of application
2. 2. Facility Information: Basic details about the pharmacy premises, operating hours, and key personnel
3. 3. Risk Assessment Methodology: Explanation of risk rating criteria and assessment process
4. 4. Dispensing and Medication Management: Assessment of risks related to prescription handling, dispensing processes, and medication storage
5. 5. Controlled Substances Management: Specific risk assessment for Schedule 8 and other controlled medications
6. 6. Storage and Environmental Controls: Assessment of storage conditions, temperature monitoring, and facility security
7. 7. Staff Safety and Training: Evaluation of staff-related risks including training needs and safety protocols
8. 8. Customer Safety: Assessment of risks related to customer interactions and public areas
9. 9. Data and Privacy Security: Evaluation of information security risks and privacy controls
10. 10. Emergency Procedures: Assessment of emergency preparedness and response capabilities
11. 11. Quality Control Measures: Review of quality assurance processes and controls
12. 12. Action Plan: Documented control measures and implementation timeline
13. 13. Review and Monitoring: Process for ongoing monitoring and periodic review of risk controls
1. Compounding Services Assessment: Additional risk assessment section for pharmacies offering compounding services
2. Vaccination Services: Risk assessment specific to pharmacies providing vaccination services
3. After-Hours Services: Additional considerations for pharmacies operating extended hours
4. Specialized Clinical Services: Risk assessment for additional clinical services like medication reviews
5. Remote/Rural Considerations: Special considerations for pharmacies in remote locations
6. Automated Dispensing Systems: Risk assessment for pharmacies using automated dispensing technology
1. Schedule A: Risk Assessment Matrix: Detailed risk rating criteria and assessment tools
2. Schedule B: Hazardous Substances Register: List of hazardous substances and specific control measures
3. Schedule C: Incident Report Form: Template for documenting and reporting incidents
4. Schedule D: Training Records Template: Documentation format for staff training and competency
5. Schedule E: Equipment Maintenance Log: Template for tracking equipment maintenance and calibration
6. Schedule F: Temperature Monitoring Log: Template for recording storage area temperatures
7. Schedule G: Security Checklist: Daily/weekly security verification checklist
8. Schedule H: Emergency Contact List: List of emergency contacts and procedures
9. Appendix 1: Relevant Legislation Summary: Summary of applicable laws and regulations
10. Appendix 2: Standard Operating Procedures: Reference to relevant SOPs for risk control
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Pharmaceutical
Retail Pharmacy
Hospital Pharmacy
Community Health
Aged Care
Primary Healthcare
Medical Centers
Healthcare Compliance
Risk Management
Relevant Teams
Pharmacy Operations
Quality Assurance
Risk Management
Clinical Governance
Compliance
Health and Safety
Professional Services
Regulatory Affairs
Operations Management
Clinical Services
Relevant Roles
Pharmacy Owner
Pharmacy Manager
Chief Pharmacist
Retail Pharmacy Manager
Hospital Pharmacy Director
Quality Assurance Manager
Compliance Officer
Risk Management Coordinator
Clinical Governance Manager
Pharmacist-in-Charge
Senior Pharmacist
Pharmacy Safety Officer
Operations Manager
Healthcare Facility Manager
Regulatory Affairs Manager
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