Complaint data sourced from the Pharmacy Council (2021-22) showed 518 complaints were made against NSW pharmacists. Of these complaints, 71 immediate action s150 hearings were conducted to address potential risk to the general public. This is a firm reminder that proprietors should be aware that they are responsible for every facet of the business, irrespective of whether they are physically present or not. Pharmacy owners must have procedures in place to guide all employees (including employed pharmacists, graduates, locums, dispensary techs, assistants, delivery drivers, contractors) to ensure they clearly understand their obligations per their position description and under the relevant legislation.
Proprietors must maintain, and be able to demonstrate an awareness of, the way that pharmacy business is being conducted. Strategies and interventions are recommended to ensure that the practice of pharmacy is conducted in accordance with relevant laws, standards and guidelines.
The accompanying Suggested Audit Areas is designed to remind all pharmacy owners that they must adhere to the Pharmacy Board of Australia document Guidelines for Proprietor Pharmacists (September 2015). A proprietor checklist and audit sample can be retrieved here.
Proprietors must ensure they have adequate oversight of their business, including protocols in place to manage monitored medicines transactions. Barcode scanning should also be used to verify correct drug selection and should occur immediately before attaching the label to minimise dispensing errors. The following are some guidelines for proprietors and management.
Guideline 1 - Proprietors to maintain an active interest in how the pharmacy business is conducted and ensure the pharmacy is operated in accordance with:
- Federal and state legislation
- Pharmacy Board of Australia (PBA) policies, codes and guidelines
- Professional Practice and Quality Assurance Standards and Guidelines
- Good pharmacy practice and quality use of medicines
Guideline 2 - Proprietor pharmacists cannot delegate their professional obligations
- Tasks can be delegated but the overall responsibility cannot
- Proprietors need to monitor task completion and assess quality of work
- Regularly review and document staff activities and performance
Guideline 3 - Responsibilities of proprietor pharmacists
- Pharmacist registration standard
- Facility and equipment compliance
- Risk Management
- Privacy and Confidentiality
- Awareness of goods and services sold
- Adequate staff and resources with an appropriate skill set
- Protocol and Procedure Development and Implementation for all activities
- Compliant advertising
There is no silent partner in pharmacy- if you own a business or receiving money from a business then you are required to have oversight. This may include:
- On-site visits
- Checklists
- Audits
- Observation of practice
- Staff meetings
- Employee check-ins and reviews
- Reporting systems
- Not just about finances
- Schedule weekly, monthly and annually
- Stock check (including S8), high risk medications, owing reports, uncollected script report, negative stock, wholesalers
- Incident reporting
- Audits
- More than a checklist
- Specific areas of practice (e.g., S4B, S4D, S8, OTP, compounding, DAA, vaccination, script owing)
- Incident management
- Identify and assess risks and near misses
- Review associated protocols and procedures
- Document, report, discuss and reflect upon all incidents and near misses
- Develop and implement improved protocols
- Call Professional Indemnity Insurance provider (PDL 1300 854 838)
Further resources:
NSW Health
NSW Legislation
Poisons and Therapeutic Goods Regulation 2008
Health Practitioner Regulation National Law (NSW) No 86a of 2009
Health Practitioner Regulation NSW Regulation 2016
Guidelines
Pharmacy Council NSW – The Guide
Quality Care 2020 Requirements
Guide to the Poisons and Therapeutic Goods legislation for poisons licence holders
Guide to the Poisons and Therapeutic Goods legislation for pharmacists