Pharmacy Risk Assessment

Pharmacy Risk Assessment Template for Ireland

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Key Requirements PROMPT example:

"I need a Pharmacy Risk Assessment for our new compounding pharmacy opening in Dublin in March 2025, with particular focus on handling hazardous materials and sterile preparation areas."

Document background

The Pharmacy Risk Assessment is a mandatory document required under Irish law for all pharmacy operations. It is designed to comply with the Pharmacy Act 2007, the Safety, Health and Welfare at Work Act 2005, and various regulations governed by the Pharmaceutical Society of Ireland (PSI). This document should be implemented when establishing a new pharmacy, during significant operational changes, or as part of regular safety reviews (minimum annually). It encompasses all aspects of pharmacy operations, including medication management, staff safety, customer protection, and specific pharmaceutical procedures. The assessment must be conducted by or under the supervision of qualified personnel and requires regular updates to reflect any changes in operations or regulations. This document forms a crucial part of the pharmacy's safety management system and can be used as evidence of compliance during PSI inspections.

Suggested Sections

1. 1. Document Control: Details of the document version, date, author, and approval status

2. 2. Pharmacy Details: Information about the pharmacy premises, registration number, and responsible persons

3. 3. Scope of Assessment: Definition of what areas and activities are covered by the risk assessment

4. 4. Methodology: Description of risk assessment methodology and scoring system used

5. 5. Hazard Identification: Systematic listing of all identified hazards in the pharmacy operation

6. 6. Risk Evaluation: Assessment of likelihood and severity of identified risks

7. 7. Control Measures: Existing and proposed measures to mitigate identified risks

8. 8. Training Requirements: Specific training needed to implement control measures and maintain safety

9. 9. Emergency Procedures: Procedures for handling accidents, incidents, and emergencies

10. 10. Monitoring and Review: Schedule and procedures for regular review and updating of the assessment

Optional Sections

1. Specific High-Risk Operations: Detailed assessment of specific high-risk activities such as compounding or vaccination services, include if these services are provided

2. Contractor Management: Assessment of risks related to contractors and external service providers, include if regularly used

3. Pregnancy Risk Assessment: Specific assessment for pregnant or nursing staff members, include if applicable

4. COVID-19 Risk Assessment: Specific assessment of COVID-19 related risks and controls, include if required by current health guidelines

5. Environmental Impact Assessment: Assessment of environmental risks and waste management procedures, include if handling hazardous waste

Suggested Schedules

1. Schedule 1: Risk Assessment Matrix: Detailed risk scoring matrix and evaluation criteria

2. Schedule 2: Hazard Checklist: Comprehensive checklist of common pharmacy hazards

3. Schedule 3: Control Measure Register: Detailed register of all control measures and their maintenance requirements

4. Schedule 4: Training Records: Records of staff training related to risk management

5. Schedule 5: Incident Report Forms: Templates for reporting safety incidents and near-misses

6. Appendix A: Floor Plan: Pharmacy layout showing high-risk areas and safety equipment locations

7. Appendix B: Safety Data Sheets: Collection of relevant safety data sheets for hazardous substances

8. Appendix C: Emergency Contact List: List of emergency contacts and response procedures

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok��˰� | 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

Retail Pharmacy

Pharmaceutical

Medical Services

Primary Care

Community Healthcare

Occupational Health and Safety

Relevant Teams

Pharmacy Operations

Health and Safety

Quality Assurance

Compliance

Risk Management

Facilities Management

Training and Development

Senior Management

Store Operations

Relevant Roles

Pharmacy Owner

Superintendent Pharmacist

Supervising Pharmacist

Staff Pharmacist

Pharmacy Technician

Pharmacy Assistant

Health and Safety Manager

Quality Assurance Manager

Operations Manager

Compliance Officer

Risk Management Officer

Store Manager

Training Coordinator

Facilities Manager

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Authors

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