Victorian Pharmacy Authority

Circular No. 37 - April 2025

In this Circular

• Chair's Message
• 2025 Licence and Registration Renewals
• Special focus: VPA Inspection Program
  
  • Statement of Regulatory Approach – Risk-based approach to inspections of registered premises
  • Inspection categories
  • Inspection outcomes
  • FAQs: Inspections

   

• From the inspectors:
  
  • Drug refrigerator temperature monitoring
  • Storage of Schedule 4 medicines

   

• Did you know? What to do during power outages to maintain cold chain integrity?
• Recent panel hearings
• For information: Seeking support
• Resources
• Members of the Victorian Pharmacy Authority
• VPA Staff

Chair's message

Welcome to the VPA’s first circular for 2025.

Inspections play a critical role in promoting and ensuring compliance with the regulatory framework.

Specifically, our goal is to regulate licensees and registered premises with a consistent standard that prioritises reducing public harm.

The VPA relies on the best available information and evidence to guide our regulatory decisions, ensuring actions are fair, reasonable, and proportionate. We will use our authority to sanction licensees who do not comply with the Pharmacy Regulation Act 2010 (the Act), VPA Standards or who act unlawfully, and we are committed to constantly refining our risk-based approach to regulation.

Last year, the VPA released a statement about our risk-based approach to inspecting registered premises. This document provides important information for stakeholders, especially about how inspections are categorised and outcomes are determined using this approach. In this circular the VPA answers common questions about inspections and highlights key points from our information evening on the VPA inspection program and risk-based approach for pharmacies, which was held on 19 June 2024.

I urge pharmacy owners and pharmacists with regulatory responsibilities to view compliance not merely as a requirement, but as a key element of effective governance and exemplary leadership.

David McConville
Chair, Victorian Pharmacy Authority

2025 Licence and Registration Renewals

Renewal notices will be sent by email in late-May for:

1. Pharmacy, pharmacy department and pharmacy depot premises registration, and
2. Licences to carry on a pharmacy business or pharmacy department.

Renewal notices are sent to registered premises only. They are not sent to individual owners.

Pharmacy owners and pharmacists in charge need to ensure appropriate distribution of renewal notices to ensure payment. Please ensure that you have notified the Authority of the current email address for any registered premises and that you have received all your renewal notices.

Registration and licence renewals must be received with payment by 30 June 2025 to avoid a late fee. Late renewal applications may then be submitted with payment of the late lodgement fee from 1 July 2025 until 28 July 2025 ("late period").

Each pharmacy registration renewal requires a licensee or director to answer questions and make declarations about the pharmacy premises, ownership and commercial arrangements before payments can be made.

If a licence or registration renewal remains outstanding after the late period, the Authority may decide not to renew the licence or registration. It will then be unlawful to continue to carry on the pharmacy business or operate in those premises. New applications will be required.

Special focus
VPA Inspection Program

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?

• www.pharmacy.vic.gov.au
• Information specifically related to inspections and the VPA’s regulatory approach can be found here: www.pharmacy.vic.gov.au/statement-of-regulatory-approach-inspections

From the inspectors

Storage of Schedule 4 medicines

Schedule 4 medicines should only be stored in the dispensary or in a lockable storage facility. Access to areas where Schedule 4 medicines are stored should be restricted to registered pharmacists or suitability trained personnel under the supervision of a registered pharmacist.

VPA inspectors have observed instances where filled Return of Unwanted Medicines (RUM) bins were stored in unsecure locations such as storerooms with unrestricted access. Returned or expired medicines should be quarantined in a secure manner and disposed of regularly to prevent build up and misappropriation. Returned or expired medicines/filled RUM bins should be stored in the dispensary or in another part of the premises under lock and key to prevent unauthorised access.

VPA inspectors have also observed medicines held to fill dosage administration aids (DAA), including unwanted/ceased DAA packs, stored outside of the dispensary in unsecure locations (such as a DAA filling room, storeroom or walkway).

• DAA filling rooms that are located away from the dispensary must be locked when not in use
• Unwanted/ceased DAA medicines (including DAA packs) should be securely quarantined and discarded to prevent the re-use of medicines.
• Clause 9(b) of the Schedule to the Act states that adequate arrangements must be in place “to ensure that medicines are not re-used after dispensing and after they have left the pharmacy or pharmacy department”.

If there is a need to store Schedule 4 medicines outside of the dispensary, licensees must ensure the additional storage area complies with the requirements for storage of medicines including maintaining suitable room temperature control, lockable facility, alarm motion sensors, restricted access and maintaining privacy of any patient information.

Drug refrigerator temperature monitoring

Temperature monitoring of drug and vaccine refrigerators must comply with National Vaccine Storage Guidelines ‘Strive for 5’. VPA Standard 2.4.2(b) requires dispensaries to be fitted with “refrigeration which is dedicated to and appropriate for the storage of medicines, with adequate temperature monitoring”.

According to the National Vaccine Storage Guidelines ‘Strive for 5’, twice-daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in the cold chain. The data logger is used to continuously measure the refrigerator temperature at preset 5-minute intervals. A data logger is used in conjunction with manual monitoring to allow for the analysis and investigation of temperature deviations. The data should be downloaded at least weekly (and as soon as possible after a temperature breach is identified), reviewed and stored.

VPA inspectors continue to observe cases where:

• twice-daily manual minimum and maximum temperature monitoring of the drug refrigerator was not undertaken and/or
• the drug refrigerator was not monitored using a temperature data logger or
• the data logger was present but not functioning e.g., battery had run out or
• the data logger was present but the data was not being downloaded and reviewed regularly and/or,
• data logger alert emails are being left unopened and not actioned.

All pharmacists should be trained on how to operate and manage the data logger and interpret its readings.

Pharmacies should have written procedures on cold chain management readily accessible by regular and locum pharmacists to support ongoing compliance.

For further information on cold chain management refer to the National Vaccine Storage Guidelines ‘Strive for 5’.

Did you know?
What to do during power outages to maintain cold chain integrity?

Written procedures on cold chain management should include procedures for investigating any temperature readings outside 2°C to 8°C to ensure the integrity of the cold chain also known as a “cold chain breach protocol”

For vaccines, a cold chain breach includes exposure of vaccines to temperatures outside the recommended range of 2°C to 8°C, excluding fluctuations up to 12°C lasting less than 15 minutes when restocking, cleaning the fridge or stock taking. Exposure of a vaccine to freezing or a temperature of 25°C or over for any period constitutes a breach.

Further information on cold chain requirements for vaccines and examples cold chain breach protocols can be found in the National Vaccine Storage Guidelines ‘Strive for 5’.

Pharmacist immunisers should also refer to the Victorian Pharmacist-Administered Vaccination Program Guidelines.

Recent panel hearings

The VPA conducted 8 panel hearings during February and March 2025 into allegations that licensees failed to meet their responsibilities to comply with the Act and VPA Standards. The VPA also conducted four meetings with licensees during this period. Panel hearings and meetings with licensees are not conducted in January.

A meeting with the VPA is less formal than a panel hearing. A meeting is usually conducted when the Authority is satisfied with the response submitted by the licensee but determines that the licensee would benefit from a meeting to discuss the matter.

Panel hearings are convened for serious potential breaches of the Act and the VPA Standards. Six hearings resulted in reprimands; two hearings resulted in the licensees being cautioned. Five of the hearings also resulted in a condition being imposed requiring a reinspection at the licensee’s cost and two hearings resulted in additional conditions being imposed relating to indirect supply arrangements relating to medicinal cannabis.

Indirect supply arrangements and medicinal cannabis continue to be areas of focus during VPA inspections.

For information
Seeking Support

The VPA recognises that receiving and responding to a non-compliance notice (report of an investigation or notice of panel hearing) can be stressful. Pharmacists are reminded to seek support during stressful times.

The Pharmacists’ Support Service (www.supportforpharmacists.org.au) is a support service run by pharmacists for pharmacists (1300 244 910). Your professional association, professional indemnity insurer or independent legal adviser can also provide support and assistance.

Resources

Supporting key learnings from recent inspections and areas of high risk, licensees and pharmacists may wish to refer to the following resources. Resources are not limited to the list below and pharmacists are encouraged to review other relevant resources as required.

VPA resources

• VPA Standards here
• VPA Guidelines here
• VPA Self Audit form here
• VPA Managing Schedule 8 poisons – a reference guide for pharmacists here
• VPA Commercial arrangement guidance here

S8 management

• Drugs, Poisons and Controlled Substances Regulations 2017 here
• Medicines and Poisons Regulation guidance document Management of Schedule 8 poisons here
• Medicines and Poisons Regulation guidance document Refrigerated storage for Schedule 8 medicines (in Victoria) here
• Pharmacotherapy policy in Victoria here
• Pharmacotherapy self-assessment – for pharmacists providing ORT here
• Pharmaceutical Society of Australia opioid replacement therapy training program and long-acting injectable buprenorphine training here

Vaccination

• Victorian Pharmacist-Administered Vaccination Program Guidelines and Secretary Approval: Pharmacist Immuniser here
• Victorian COVID-19 Vaccination Guidelines here
• National Vaccine Storage Guidelines ‘Strive for 5’ here

Other resources

• Pharmacy Board of Australia Guidelines on compounding medicines here
• Joint statement on compounded medicines – Pharmacy Board of Australia and Medical Board of Australia here
• Therapeutic Goods Administration (TGA) GMP information for manufacturers of compounded medicines and DAAs here
• TGA Medicinal cannabis hub here
• TGA Medicinal cannabis - guidance documents here
• TGA Advertising guidance for businesses involved with medicinal cannabis products here
• Medicines and Poisons Regulation guidance document Dispensing medicines here
• Pharmacy Board of Australia Guidelines for dispensing of medicines here
  Pharmacy Board of Australia Guidelines for proprietor pharmacists here
• Pharmacy Board of Australia's Guidelines on practice-specific issues here
• Pharmacy Board of Australia Guidelines on practice-specific issues - Guideline 1 (List of reference texts for pharmacists) here
• Pharmacy Board of Australia Guidelines on dose administration aids and staged supply of dispensed medicines here
• Pharmaceutical Society of Australia Guidelines for Pharmacists Providing Dose Administration Aid Services here
• Pharmaceutical Society of Australia Professional Practice Standards 2023 here
• Pharmaceutical Society of Australia Clinical Governance Principles for Pharmacy Services here

Members of the Victorian Pharmacy Authority

Mr David McConville, Chair (Pharmacist member)
Ms Regina Cowie (Pharmacist member)
Ms Jane Hill (Community member)
Ms Elizabeth Kennedy (Lawyer member)
Mr Brendon Moar (Pharmacist member)
Mr Divesh Sanghvi (Pharmacist member)

VPA Staff

Registrar: Mr Aaron Bawden
Chief Finance Officer: Ms Koshala Nadanakumar
Senior Pharmacist: Ms Jessica Webster
Administration Officer: Ms Helen Newett
Pharmacist: Dr Jill Snell (Governance and Risk Officer)
Pharmacist: Ms Maggie Bassily (Project and Engagement Officer)
Pharmacist: Ms Tran To (Project and Engagement Officer) [currently on leave]
Pharmacist: Ms Karen La (Authorised Officer)
Pharmacist: Mr Scott Savage (Authorised Officer)
Pharmacist: Ms Denise van den Bosch (Authorised Officer)
Pharmacist: Ms Annie Luu (Authorised Officer)

The VPA Circular is a document issued by the Victoria Pharmacy Authority (VPA) in Australia. It provides important information and updates to pharmacists and pharmacy stakeholders. You can review this circular and previous circulars on the VPA website here.