Pharmacy Risk Assessment Template for New Zealand

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Key Requirements PROMPT example:

Pharmacy Risk Assessment

"I need a Pharmacy Risk Assessment for a new 24-hour pharmacy opening in Auckland CBD in March 2025, with specific focus on after-hours security measures and automated dispensing systems."

Document background

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.

Suggested Sections

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

Optional Sections

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

Suggested Schedules

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

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

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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