Victorian Pharmacy Authority

Circular No. 35 - September 2024

In this Circular

• Chair's Message
• David Thirlwall retires
• Jessica Webster appointed Senior Pharmacist
• Welcome Jane Hill and farewell Marie Ritchie
• Special Focus: Improvements to the Inspection Program
  
  • Inspection Program Information Evening
  • Improved pharmacy self-audit form
  • Feedback on VPA inspections

   

• Statement of Regulatory Approach: Risk-based approach to inspection of registered premises
• Revised VPA Guidelines
• Applications
  
  • Application processing times / Service standards
  • Incomplete applications
  • Updated VP21 Form and Checklist - now available

   

• Resources
• Members of the Victorian Pharmacy Authority
• VPA Staff

Chair's Message

It has been a period of significant change at the VPA. We celebrated Senior Pharmacist David Thirlwall’s retirement earlier this year and recognised his many contributions to the work of the VPA. Experienced VPA inspector Jessica Webster stepped into the Senior Pharmacist role from April this year.

We thank Marie Ritchie for her contributions as an Authority member. Marie recently completed her second 3-year term as a community member of the VPA. We welcome Jane Hill, an accomplished leader in health and community services, who was appointed as a community member from 1 July 2024.

It was pleasing to see and meet many licensees, pharmacists and stakeholders at our recent hybrid information evening on the VPA inspection program and risk-based approach for pharmacies. The session highlighted licensees’ compliance obligations under the regulatory framework and high-risk areas which typically form the focus of inspections. Our recently published Statement of Regulatory Approach includes information on the risk-based approach and is intended to support licensees to develop a strong and effective compliance culture.

An increased focus on risk management requires licensees to identify and
appropriately manage risks in their pharmacies and pharmacy departments. The updated VPA self-audit form is a valuable tool designed to assist licensees and pharmacists with this task by auditing their compliance with key requirements of the Act, VPA Standards, VPA guidelines and good pharmacy practice. The revised VPA Guidelines also include new guidance to support compliance with the standards relating to risk management. 

David Thirlwall retires

Earlier this year, we farewelled VPA Senior Pharmacist David Thirlwall.

David commenced his pharmacy career as a pharmacy student in 1966. During his career as a pharmacist, David was a pharmacy owner, then a Drugs and Poisons Officer at the Department of Health from 1991-1997. David joined the VPA’s predecessor, the Pharmacy Board of Victoria, as Senior Pharmacist in 1997.

David’s contributions to the VPA and former board over more than 26 years include:

• establishing comprehensive inspection protocols covering a range of pharmacy services
• leading the VPA’s team of inspectors for many years
• the introduction of a program to address risks relating to sterile
  compounding
• new processes to assess pharmacy business commercial arrangements.

David will be missed very much by the VPA team and Authority members for his unwavering support and willingness to assist others, his extensive pharmacy knowledge, meticulous attention to detail and mastery of the English language. He has been a great contributor to the VPA culture and the maturity of the VPA as a regulator. We wish him well in his retirement.

Jessica Webster appointed Senior Pharmacist 

Experienced VPA inspector Jessica Webster commenced in the role of Senior Pharmacist from April this year after acting in the role. Jessica is responsible for compliance monitoring and planning. She leads a team of inspectors and assesses applications for premises registration including new and altered pharmacies.

Welcome Jane Hill and farewell Marie Ritchie

Jane Hill was appointed by the Governor in Council as a community member of the VPA (a member who is not a registered pharmacist) for a three-year term from 1 July 2024 until 30 June 2027.

Jane is an accomplished leader in health and community services and currently serves as Vice Chair of the World Ovarian Cancer Coalition, an organization focused on improving survival rates for individuals with ovarian cancer around the world. From 2015 to 2023, Jane was the CEO of Ovarian Cancer Australia, where her exceptional efforts in addressing the challenges of gynaecological cancers, earned her the prestigious Cancer Australia Jeannie Ferris Award. Jane’s contributions also extend into the pharmacy sector. Earlier in her career, as Executive Manager of the Society of Hospital Pharmacists of Australia Jane gained an appreciation of the vital role of pharmacy practice and its various specialties.

Marie Ritchie completed her second 3-year term as a community member of the VPA on 30 June 2024. During her two terms, Marie's understanding of consumer needs and the importance of a safe pharmacy system were integral to the culture, function and focus of the VPA board. We thank Marie for her dedication, passion and sense of fun she brought to her role and wish her the best in her future pursuits.

VPA Chair David McConville and pharmacist member Brendon Moar were both reappointed for a three-year term from 30 June 2024 until 30 June 2027.

Special Focus
Improvements to the inspection program

In line with contemporary regulatory practice, the VPA’s inspection program now includes 

• new inspection categories
• new inspection forms and decision tools for inspectors
• clearer inspection reports categorising non-compliance under relevant areas of the regulatory framework
• a focus on compliance with the VPA Standards and other high-risk areas during inspections.

It is expected that the focus on high-risk areas during inspections will result in more efficient inspections and greater opportunities for licensees to self-audit compliance in low-risk areas.

For certain inspection outcomes,
licensees are given the opportunity to report back to the VPA providing evidence of steps taken to address non-compliances. A comprehensive and satisfactory response may result in inspection reports being handled administratively and not referred to a meeting of Authority members for consideration of further action, which could include being requested to attend an interview or panel hearing.

Inspection program information evening

The VPA would like to thank all licensees, stakeholders and pharmacists who attended our hybrid
information evening on the VPA inspection program and risk-based approach for pharmacies on 19 June 2024. We hope attendees found the evening valuable. 

FAQs from the Inspection Program Information Evening will be made available shortly.

Updated premises self-audit form

The VPA self-audit form is designed to assist licensees and pharmacists to monitor their compliance with key
requirements of the Act, VPA Standards, VPA Guidelines and good pharmacy practice. Improvements were recently made to the pharmacy self-audit form to highlight high-risk areas routinely covered during VPA inspections, including frequently observed non-compliances. 

It is recommended that newly established services or high-risk areas are audited at least twice a year.  As systems become stable and well documented, the audit frequency can reduce to at least annually. There are separate self-audit forms for specific pharmacy services.

The VPA self-audit form also provides a useful tool for
licensees to prepare for inspections. The current version of the self-audit form dated 30 June 2024 is available here.

Feedback on VPA inspections

The VPA welcomes feedback and provides a link in covering letters to inspection reports for licensees to provide feedback on inspection processes. Feedback received may be used to review inspection processes
and for internal training purposes.

An improved process to proactively obtain feedback from pharmacists on VPA inspections was developed for the 2024-25 financial year. 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.

Statement of Regulatory Approach
Risk-based approach to inspections of registered premises

The VPA recently published a Statement of Regulatory Approach, which outlines the risk-based approach to inspections of registered premises. 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. 

The Statement of Regulatory Approach is available the VPA website here.

Revised VPA Guidelines

The VPA Guidelines

• represent the current ‘policies’ of the VPA in relation to licensing and registration; any departure from them should be justified on a case-by-case basis
• support the VPA Standards and requirements of the Act 
• should be read in conjunction with
  
  • the VPA Standards and the Schedule to the Act
  • guidelines issued by the Pharmacy Board of Australia 
  • standards and guidelines issued by pharmacy professional organisations

   

The VPA would like to thank all stakeholders who took the time to read, comment and provide feedback on the draft revised guidelines. An unprecedented level of feedback was received following stakeholder consultation.

The updated guidelines include new guidelines to support licensees to comply with standards under which guidelines have not previously been issued (including guidelines relating to policies and procedures, quality improvement and risk management, hygiene and infection prevention and equipment). Other guidelines have been updated or amended. 

In revising the guidelines, the VPA’s primary goal is to support licensees and pharmacists to comply with its standards and the requirements of the Act. The VPA aims to produce guidelines which are consistent with, and do not duplicate guidelines issued by other pharmacy organisations or regulators. 

The revised VPA Guidelines take effect from 5 September 2024 and can be viewed along with a document summarising the changes on the VPA website here.

The VPA recognises that the requirement to display the names of directors for company licensees (G1.2.1.1) will require time to implement and will allow a period of one month for licensees to familiarise themselves with the revised guideline and make the necessary changes.

Applications
Application Processing times / Service standards

The VPA commits to manage all applications efficiently in accordance with its Service Charter.

The following standards of service have been set by the VPA in relation to applications:

• The VPA aims to commence the assessment of and provide initial feedback on applications within 10 business days of receipt of a complete application. This includes,
  at a minimum, details of further information which may be required by the VPA to determine the application, based on the initial assessment.
• For applications within the delegation of VPA officers, processing should be completed within a further five business days of receipt of any outstanding information. For applications outside delegation, processing should be completed within five business days following a decision of the next monthly meeting of Authority members or receipt of any further required information.
• The Authority updated its Service Charter in February
  2024. The increase in the ‘initial assessment’ time from 5 to 10 days was made to reflect the increasing complexity of applications, reflected in increased numbers of complex licence applications and corporate licence applications over recent years.

The updated Service Charter is available on the VPA website here.

Applications
Incomplete Applications

Applicants are encouraged to ensure that all the required information is included with the application prior to submitting. Incomplete applications can delay processing times significantly. Some examples of common issues and omissions include:

• old application forms being used/submitted (forms should be downloaded directly from the website rather than using an internet search which may result in links to obsolete forms)
• not addressing each item/question on an application
• missing pages
• plans not submitted in accordance with application form (floor plans elevation plans and location plans are all required)
• plans incomplete, not correctly labelled, unclear or generally of poor quality
• no fee payment or incorrect fee paid
• not providing the correct supporting documentation
• unexecuted documents (i.e. either not signed, not signed by all relevant parties or not dated)
• delayed responses to requests for further information or responses which are unclear, vague or do not address the
  question.

Applications
Updated VP21 form and checklist

The VPA made recent improvements to the Application for Registration of Pharmacy Premises (VP21) form to better reflect requirements of the VPA Standards. The updated and reformatted application form included a new comprehensive checklist to assist applicants to complete applications and submit the required information to help avoid delays caused by incomplete applications.  

In line with the VP21 application form updates, the VP35 Completion of alterations to existing pharmacy premises and VP36 Completion of new pharmacy premises notification forms were also updated. Applicants should note that some
questions require submission of photographic evidence alongside the lodgment of the notification forms.

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
• Secretary Approval: Pharmacist Immunisers SARS-CoV-2 (COVID-19) VACCINE here
• Victorian COVID-19 Vaccination Guidelines here
• National Vaccine Storage Guidelines ‘Strive for 5’ here
• ATAGI site requirements for COVID-19 vaccination in community pharmacies 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
Licensing and Registration Officer: Mr Sean Nilan
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.