The Pharmacy Risk Assessment is a crucial document required for pharmacy operations in New Zealand, designed to ensure compliance with various regulatory requirements and maintain safe pharmaceutical practices. This assessment becomes necessary when establishing a new pharmacy, during regular safety reviews, after significant operational changes, or when required by regulatory authorities. The document comprehensively evaluates risks related to medicine handling, staff and customer safety, controlled substances management, and data protection, while ensuring compliance with the Medicines Act 1981, Health and Safety at Work Act 2015, and other relevant New Zealand legislation. It serves as both a compliance tool and a practical guide for maintaining safe and effective pharmacy operations.
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1. Executive Summary: Overview of the key findings and critical risks identified in the assessment
2. Scope and Objectives: Definition of the assessment's scope, objectives, and methodology used
3. Facility Information: Details of the pharmacy premises, operating hours, and general setup
4. Operational Overview: Description of pharmacy services, staff structure, and basic workflows
5. Medicine Storage and Handling: Assessment of medicine storage conditions, security measures, and handling procedures
6. Controlled Substances Management: Evaluation of controlled drugs management, security, and record-keeping
7. Staff Safety Assessment: Analysis of staff safety measures, including physical and biological hazards
8. Customer Safety Assessment: Evaluation of public areas and customer safety measures
9. Dispensing Process Risk Analysis: Detailed assessment of prescription handling and dispensing risks
10. Hazardous Materials Management: Assessment of handling, storage, and disposal of hazardous substances
11. Data Security and Privacy: Evaluation of patient data protection and privacy measures
12. Emergency Procedures: Assessment of emergency preparedness and response procedures
13. Risk Mitigation Strategies: Recommended actions and controls to address identified risks
14. Monitoring and Review: Procedures for ongoing monitoring and periodic review of risk controls
1. Compounding Services Assessment: Required when the pharmacy provides compounding services, assessing specific risks related to medicine compounding
2. Vaccination Service Risk Assessment: Needed for pharmacies providing vaccination services, including specific clinical risk assessment
3. After-Hours Service Assessment: Required for pharmacies operating extended hours or 24/7 services
4. Automated Dispensing Systems: Necessary for pharmacies using robotic or automated dispensing systems
5. Clinical Services Risk Assessment: Required for pharmacies offering additional clinical services like health screening or monitoring
6. Online/Delivery Service Assessment: Needed for pharmacies offering online ordering and delivery services
1. Schedule 1: Risk Assessment Matrix: Template for risk evaluation scoring and prioritization
2. Schedule 2: Incident Report Forms: Standard templates for recording and reporting incidents
3. Schedule 3: Safety Equipment Checklist: Inventory and inspection checklist for safety equipment
4. Schedule 4: Hazardous Substances Register: Detailed list of hazardous substances and their management requirements
5. Schedule 5: Emergency Contact List: List of emergency contacts and response procedures
6. Schedule 6: Staff Training Records: Templates for recording staff training and competency assessments
7. Appendix A: Regulatory Compliance Checklist: Checklist of relevant regulatory requirements and compliance status
8. Appendix B: Floor Plan and Safety Zones: Detailed pharmacy layout marking critical safety areas and equipment
9. Appendix C: Standard Operating Procedures: Key SOPs referenced in the risk assessment
10. Appendix D: Audit Tools: Templates and checklists for regular risk assessment reviews
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Pharmaceutical
Retail Pharmacy
Healthcare Compliance
Occupational Health and Safety
Medical Services
Healthcare Risk Management
Professional Services
Public Health
Regulatory Compliance
Relevant Teams
Operations
Pharmacy
Quality Assurance
Risk Management
Compliance
Health and Safety
Clinical Services
Professional Services
Regulatory Affairs
Senior Management
Human Resources
Training and Development
Relevant Roles
Pharmacy Manager
Pharmacist
Pharmacy Technician
Health and Safety Officer
Quality Assurance Manager
Compliance Officer
Risk Management Specialist
Operations Manager
Clinical Services Manager
Professional Services Manager
Retail Manager
Healthcare Facility Manager
Regulatory Affairs Specialist
Pharmacy Owner
District Health Board Manager
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