Statement of Regulatory Approach: Risk-based approach to inspections of registered premises
The VPA’s Statement of Regulatory Approach is available on the VPA website here: www.pharmacy.vic.gov.au/statement-of-regulatory-approach-inspections.
The Statement of Regulatory Approach provides an overview for stakeholders of the regulatory approach taken by the VPA when carrying out its regulatory activities, including inspections of registered premises. It is also intended to support regulated entities (licensees) to develop a strong and effective compliance culture.
Inspection categories
What are the triggers for an inspection?
There are three main categories of inspections:
1. Proactive inspections: Proactive inspections are planned inspections for a known cohort of registered premises identified using the VPA’s risk-based approach and are sub-categorised as follows:
- Routine: Each registered premises is routinely inspected at least every three years
- Risk-based: Inspections of registered premises are triggered when the following circumstances exist, based on relative risk:
- New premises
- Change of ownership
- Altered premises
- Random: A subset of registered premises are randomly selected for inspection, including premises that may have been inspected during the previous 3 years.
2. Reactive inspections: Reactive inspections are triggered by complaints or notifications made under the Act. Where necessary, the VPA uses its risk-based approach to triage and prioritise its reactive inspections. Reactive inspections are sub-categorised as follows:
- Complaints: Inspections may be triggered by a complaint
- Notifications: Inspections may be triggered by a notification made under the Act
- Review: There are two types of review inspections, inspector-initiated review inspections and reinspection of compliance issues identified following a panel hearing (imposed as a condition by the panel).
3. Targeted inspections: Targeted inspections are reserved for systemic or emerging risks, which may be undertaken in collaboration with other regulatory bodies.
Inspection outcomes
What outcomes can result from an inspection?
Inspection outcomes are divided into four response levels:
1. Level 1 – Support
- Low risk, no instances of non-compliance relating to VPA Standards. May include limited instances of non-compliance relating to good pharmacy practice
- Satisfactory and encourage continuing compliance.
2. Level 2A – Rectify & Notify
- Medium risk, some instances of non-compliance relating to VPA Standards and good pharmacy practice
- Room for improvement
- The licensee is required to rectify the non-compliances and certify that they have done so.
3. Level 2B – Rectify & Report
- High risk, significant non-compliance with the VPA Standards
- Significant room for improvement
- The licensee is required to rectify the non-compliances, certify that they have done so and provide a written response to the inspection report, including evidence, which may be considered by the Authority at a meeting of its members.
4. Level 3 – Refer to Authority
- Extreme risk, widespread non-compliance with requirements of the Act and/or VPA Standards
- The licensee is required to rectify the non-compliances and provide a written response to the inspection report, including evidence, for consideration by the Authority at a meeting of its members.
FAQs: Inspections
1. What is the purpose of inspections?
- The VPA’s inspection program plays a critical role in promoting and ensuring compliance with the regulatory framework. While inspections are used to determine whether or not a registered premises complies with the Act, VPA Standards and VPA Guidelines, the primary purpose of inspections is to support licensees and pharmacists to understand and comply with the requirements of the regulatory framework.
2. What is the focus of inspections?
- Inspections typically focus on compliance with the VPA Standards (referred to as a “Standards Inspection”) but also requirements of the Act, VPA Guidelines and good pharmacy practice. However, the scope of an inspection may depend upon the inspection category and the pharmacy services provided (see above for types/categories of inspection).
3. What should I expect at an inspection?
- The inspector will identify themselves and show their identification
- The purpose of the inspection and the inspection process will be explained
- The inspector should conduct themselves in a courteous and professional manner
- The inspection should be conducted in an efficient manner
- VPA inspectors should demonstrate a sound understanding of pharmacy legislation, VPA Standards and good pharmacy practice
- The inspector should provide explanations for their main observations and sufficient opportunity to comment
- The inspector will provide information about what to expect after the inspection and how to respond to the inspection report.
4. How can I prepare for an inspection?
- The VPA self-audit form (available on the VPA website) has recently been improved to highlight areas routinely covered during inspections to better prepare pharmacies for inspection
- Having relevant policies and procedures in place and performing regular self-audits will also help prepare for inspections
- Inspectors will increasingly look for completed self-audits as evidence of quality improvement activities.
5. How does the VPA determine the outcome/response level of inspections?
- The outcome is determined by the nature of the non-compliances, and whether they are related to the Act, VPA standards and/or requirements relating to good pharmacy practice. The relative risk associated with non-compliance with the Act and VPA Standards is likely to be higher compared to non-compliance with good pharmacy practice. Similarly, the risk is greater for a larger number of non-compliances
- The risk profile of the regulated entity is also considered, with compliance history and the general attitude towards compliance taken into account
- Licensees are notified of the inspection outcome in a letter emailed to the registered premises along with a covering letter. The covering letter contains information about the expected response and varies depending on the inspection outcome
- For more information on inspection outcomes, response levels and how the VPA determines the level of risk, refer to our Statement of Regulatory Approach document here.
6. How does the VPA ensure a consistent approach to inspections by inspectors?
- The inspectors use standardised checklists covering relevant requirements of the regulatory framework to guide their approach to inspections
- To ensure a consistent approach, VPA inspectors undertake regular training, meet regularly to consider feedback and agree on approaches to inspections and regularly conduct inspections jointly with other officers
- Improvements have recently been made to ensure that inspections focus primarily on high-risk areas, with more opportunities for licensees to monitor their compliance through self-auditing
- The focus of inspections may differ depending on the reason for the inspection, the inspection category, the pharmacy services provided and the VPA’s regulatory priorities.
7. What if I don’t agree with the inspector?
- The covering letter to the inspection report contains guidance on what to do in the case that you have any questions or do not agree with the inspector’s findings
- In the first instance it is best to contact the VPA officer (inspector) who conducted the inspection
- You may also refer the matter to the Authority in writing detailing your reasons
- Compliance with the VPA Standards is mandatory. The Authority cannot grant exemptions in the case of requirements relating to the VPA Standards (e.g. the requirement for a sink with an integrated drainer or the requirement to have scales). The Authority may only consider requests for exemptions relating to the VPA Guidelines and licensees should be able to demonstrate that related requirements of the Act or VPA Standards are being met.
8. How do I provide feedback?
- The VPA encourages and welcomes feedback on inspection processes to help identify opportunities for continuous improvement
- A link is routinely provided in covering letters to inspection reports for licensees to provide feedback on inspection processes
- A process for seeking feedback proactively has also been developed. On a quarterly basis, 20 inspected premises will be randomly selected to provide feedback via a short, focused questionnaire. The process includes the development of metrics to determine the effectiveness of the inspection program to address public harms
- Feedback received may be used to review inspection processes and for internal training purposes.
9. Why are some inspections undertaken on a random basis?
- Undertaking a subset of inspections on a limited and random basis enables a more accurate estimate of the rate of non-compliance with high-risk areas covered by the VPA Standards
- To assist the VPA to measure the impact of inspections.
10. Can the VPA give advance notice of inspections?
- Inspections are typically undertaken without notice as this allows inspectors to observe the pharmacy as it normally operates
- Having relevant policies and procedures in place and performing regular self-audits will help prepare for inspections
- If it is not possible to obtain all the required information on the day of the inspection, inspectors often follow up with licensees or pharmacists in charge to clarify matters after an inspection
- VPA may provide notice of inspections in particular circumstances.
11. Will the VPA publish information about inspections?
- The VPA does not currently publish information about particular premises
- Inspection reports are confidential. The VPA may publish deidentified data relating to trends in compliance with the VPA Standards in the future.
12. Is the inspection checklist available to licensees?
- Inspection forms/checklists are not made available to licensees as they are not in a suitable format to aid compliance
- The VPA self-audit form (available on the VPA website) has recently been improved to highlight areas routinely covered during inspections to better prepare pharmacies for inspection.
13. Where can I find further information?