In this Circular

Chair's message

Welcome to the VPA’s December circular.

In this circular, we include information on the VPA’s approach to pharmacy franchising in the context of recent industry developments. On behalf of the members of the VPA, I reiterate our ongoing commitment to ensuring that all Victorian pharmacies are owned, operated and controlled only by registered pharmacists.

Other focus areas relate to compounding, including sterile compounding, and medicinal cannabis. We highlight important considerations for pharmacists considering compounding medicinal cannabis, and information on sterile compounding following the recent TGA alert about compounded semaglutide-like products. There is also important information about holding stock of medicinal cannabis.

A highlight of this year has been the introduction of a new, improved inspection program, which focuses on compliance with the VPA Standards. We look forward to providing further information about our new approach to inspections in the new year.

At this time of the year, we remind proprietors to renew your AHPRA registration by 31 December if you haven't already done so, given the significant implications of a lapsed registration on a licensee’s eligibility to continue to hold a pharmacy business licence.

On behalf of the VPA members and staff, I wish you a happy and safe festive season and best wishes for the new year.

David McConville
Chair

Special focus

Pharmacy franchising and recent industry developments

The VPA responds to the 12 December 2023 Pharmacy Guild of Australia, Victorian Branch media release Response to ASX Reverse-Listing of Chemist Warehouse.

The VPA remains committed to ensuring that all Victorian pharmacies are owned, operated and controlled only by registered pharmacists and will closely monitor this development as it does other pharmacy industry developments.

The VPA acknowledges the Guild’s concerns relating to pharmacy ownership and franchising, and is prepared to act in accordance with its powers under the Pharmacy Regulation Act 2010 to uphold the ownership and control provisions of the Act. This can include the investigation of a matter based on a notification about a licensee if a person has information indicating that the:

• licensee has contravened the requirements regarding ownership of pharmacies
• licensee is no longer eligible to hold a licence
• licensee has contravened the Act, or
• licence has been improperly obtained because the Authority was provided with false or misleading information.

The VPA continues to scrutinise ownership structures and commercial agreements to ensure they do not contravene the Act and will not issue a licence to a person to carry on a pharmacy business if proposed ownership or commercial arrangements are non-compliant.

Licensees are also reminded of their obligation to inform the VPA of proposed changes to pharmacy business commercial agreements prior to those changes taking effect. This is a condition of all licences.

Applicants are encouraged to seek independent advice regarding compliance of proposed structures and commercial agreements. Commercial arrangement guidance is available on the VPA website to assist stakeholders to ensure that pharmacy business commercial arrangements comply with the Act.

Pharmacy vendors may also wish to ask prospective purchasers whether the commercial agreements they propose to carry on the pharmacy under have been drafted with reference to the ownership and undue influence provisions of the Pharmacy Regulation Act 2010, and if the agreements have been previously reviewed by the VPA. This is because licence applications involving new agreements are routinely referred for legal review and this may result in extended processing times and potential delays to settlement of purchase.

It is again disappointing that statements made in some of the related media coverage include claims that Australian pharmacies are “owned” by the franchisors or banner groups providing services to pharmacy businesses. Only registered pharmacists, pharmacist companies and eligible friendly societies may own pharmacies in Victoria.

The VPA will continue to ensure that legislated ownership provisions are upheld. This is supported by comprehensive licence application assessment processes, pharmacy ownership audits and franchise reviews.

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The guidance information contained in the following sections is intended to be general in nature and by no means exhaustive. If you are unsure about how particular requirements apply to your pharmacy, contact the Victorian Pharmacy Authority or the relevant agency.

Focus on medicinal cannabis

Medicinal cannabis compounding - TGO 93

The VPA wishes to highlight to pharmacists that specific additional requirements apply when compounding medicinal cannabis.

The Therapeutic Goods (Standard for Medicinal Cannabis) Order 2017 (TGO 93) is a standard that specifies minimum quality requirements for medicinal cannabis products. TGO 93 was amended on 28 March 2022 with new requirements for products released for supply on or after 1 July 2023.

There are specific requirements relating to:

• Labelling/child resistant packaging
• Testing
• Microbiological attributes

Pharmacist compounders (without a TGA manufacturing licence) intending to compound medicinal cannabis must ensure that relevant requirements of TGO 93 are met. This includes:

• Source of the active ingredient and evidence of compliance that is valid at the time of each compounding activity
• Evidence of compliance is kept on file at least until the end of shelf-life
• Other ingredients used in the manufacture of the medicinal cannabis product meet quality standards as defined by the Therapeutic Goods Act 1989.  Quality includes the composition, strength, potency, stability, purity, bioburden, construction, and performance characteristic of the goods.

TGO 93 guidance and FAQs are available on the TGA website here:
https://www.tga.gov.au/resources/resource/guidance/conforming-therapeutic-goods-standard-medicinal-cannabis-tgo-93-order-2017.

The VPA strongly recommends that pharmacists considering compounding medicinal cannabis products obtain professional and/or legal advice and undertake a risk assessment to ensure that relevant requirements are met.

Holding stock of unapproved medicinal cannabis products in pharmacies

Licensees are reminded that unapproved medicinal cannabis products can only be prescribed and supplied via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme and are not registered on the ARTG. It is illegal for a pharmacist to hold stock of any unapproved medicine which has not been authorised for supply to a specific patient.

Storage of medicinal cannabis products is also of concern, particularly for pharmacies which manage a high volume of medicinal cannabis dispensing. The management of Schedule 8 (S8) poisons is a high-risk area posing a significant risk to public safety and non-compliance may result in a panel hearing. Licensees are responsible for ensuring that all medicines and poisons are managed in accordance with legislation and good pharmacy practice (VPA standard 1.1.3) and this includes the management of S8 poisons.

Licensees must ensure they have sufficient drug safe capacity for the volume of products which they may need to obtain for patients. Medicines and Poisons Regulation (MPR), Department of Health, is also carefully monitoring this area of pharmacy compliance in accordance with the Drugs, Poisons and Controlled Substances Regulations and their guidance document Management of Schedule 8 poisons.

Advertising guidance for businesses involved with medicinal cannabis products

The Therapeutic Goods Administration (TGA) has published the new version of advertising guidance for businesses involved with medicinal cannabis.

It is unlawful to advertise:

• prescription medicines such as medicinal cannabis
• consultations for, or prescribing of, medicinal cannabis as part of a health service.

Focus on sterile compounding

Sterile compounding and compounded semaglutide

The VPA has strict requirements for pharmacies undertaking sterile compounding to ensure that risks for consumers and compounders are appropriately mitigated. Sterile medicines may only be compounded if the premises and equipment meet current relevant Australian Standards and staff are suitably trained in the preparation of sterile medicines.

Officers of the VPA carry out inspections of pharmacies undertaking complex compounding to monitor compliance with requirements of the Act, relevant standards and guidelines. Pharmacists involved in sterile compounding should expect more frequent inspections due to the risks involved. Targeted inspections may also be carried out in response to the identification of specific risks.

The Therapeutic Goods Administration (TGA) recently issued a Safety alert about compounded semaglutide-like products. The alert can be viewed on the TGA website here: https://www.tga.gov.au/news/safety-alerts/compounding-safety-information-semaglutide-products.

The VPA encourages pharmacists involved in the compounding and/or supply of compounded sterile products to review the TGA alert and reminds pharmacists that:

• The compounding exemptions in therapeutic goods legislation apply only to medicines compounded for specific patients (i.e., a specific patient must be identified before compounding can commence)
• Compounding medicines for bulk supply in anticipation of patients’ needs is not permitted under compounding exemptions (i.e., a manufacturing licence is required)
• It is unlawful to advertise prescription-only medicines to the public.

Pharmacists are advised to contact the TGA if there is doubt about whether a compounding activity is permitted under therapeutic goods legislation.

As mentioned in the TGA alert, pharmacists should also refer to the Pharmacy Board of Australia guidelines and the Joint statement on compounded medicines - Pharmacy Board of Australia and Medical Board of Australia (particularly item 3.1) available on the Board's website.

Applications

Updated premises registration application and notification forms

Application and notification forms are being updated to clarify requirements under relevant standards.

An updated VP21 Application for Registration of Pharmacy Premises will shortly be added to the VPA website, along with the corresponding notification form. The updated VP21 application form will also include a comprehensive checklist for applicants to help avoid delays caused by incomplete applications.

Other forms will be updated in the new year and the VPA is working with other pharmacy premises regulators to identify common reasons why applications are delayed.

Welcome Annie Luu

The VPA welcomes Ms Annie Luu to its staff as an inspector. Annie is an experienced registered pharmacist. Her primary focus will be community pharmacy inspections. Annie commenced her employment with the VPA in November 2023.

For information

Appointments to the Victorian Pharmacy Authority

The Hon. Mary-Anne Thomas MP, Minister for Health, Health Infrastructure and Medical Research is pleased to invite applications for appointments to the following three (3) positions on the Victorian Pharmacy Authority (Authority):

• Chairperson (for a registered pharmacist only)
• Pharmacist member (for a registered pharmacist only)
• Community member (for a non-pharmacist only)

These positions provide an exciting opportunity for suitably qualified and experienced individuals to contribute to the governance of the Authority and protection of the Victorian public.

These are paid, part-time Victorian Governor-in-Council appointments. The term of these appointments is up to three years from 1 July 2024.

The Victorian Government is committed to ensuring that government boards and committees reflect the composition of the Victorian community. This includes appropriate representation of women, regional Victorians, Aboriginal people, young Victorians, Victoria’s culturally diverse community, Victorians with disabilities and LGBTIQ Victorians. Recruitment will consider both merit and diversity during assessment to ensure that the Authority is high functioning and reflects Victoria’s diversity.

Applications can be made on the Victorian Join a public board website and close on 12 January 2024 at 11.59pm.

For enquiries, please contact Kim Longmore, Senior Project Officer at the Department of Health on (03) 9821 6966.

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 Elizabeth Kennedy (Lawyer member)
Mr Brendon Moar (Pharmacist member)
Ms Marie Ritchie (Community member)
Mr Divesh Sanghvi (Pharmacist member)

VPA staff

Registrar: Mr Aaron Bawden
Chief Finance Officer: Ms Koshala Nadanakumar
​Acting Senior Pharmacist: Ms Jessica Webster
Senior Pharmacist: Mr David Thirlwall [currently on leave]
Administration Officer: Ms Helen Newett
Pharmacist: Dr Jill Snell (Governance and Risk Officer)
Pharmacist: Ms Tran To (Project and Engagement Officer) [currently on leave]
Pharmacist: Ms Maggie Bassily (Project and Engagement Officer)
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)

Address: Level 2, 15-31 Pelham Street, Carlton, Victoria, Australia 3053
Telephone: (03) 9653 1700
Email: enquiries@pharmacy.vic.gov.au
Website: www.pharmacy.vic.gov.au