In this Circular

Chair's message

Welcome to the VPA’s December circular.

A highlight of this year has been the introduction of the VPA Standards which clarify the mandatory requirements for licensees and premises registered by the VPA. Subsequently, the VPA Guidelines, VPA Self-Audit form and inspection report have all been reformatted to align with the standards. The FAQs on the standards are now available on the VPA website. These will help support licensees who were unable to attend the recent webinars on the standards.

The VPA has completed the third year of its pharmacy ownership audit program and plans to continue ownership audits based on notifications and intelligence from its regulatory activities. Comprehensive reviews of new and established franchise and other complex commercial agreements will also continue to be undertaken on a risk basis. These programs support the VPA’s commitment to ensuring that pharmacies are owned and controlled only by registered pharmacists in accordance with the Act.

This circular includes an update on the provision of approval information to PBS Approved Suppliers for applicants applying to the VPA for a licence and/or premises registration.

From the inspectors, there is an emphasis on the appropriate management of Schedule 8 poisons. We also include information for licensees considering the installation of automatic machines in pharmacies.

Proprietors are reminded to renew their AHPRA registration by 31 December given the significant implications of a lapsed registration on a licensee’s eligibility to hold a licence to carry on a pharmacy business.

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 ownership audit program Year 3 and Program Evaluation Report

The VPA committed to a program of risk-based ownership audits of pharmacy businesses for at least three years to detect unlawful ownership. The ownership audit program was introduced to address the perception among pharmacists that there are breaches of the Pharmacy Regulation Act 2010 (the Act) in regard to undeclared interests. All three reports are now available on the VPA’s website here.

A total of 140 ownership audits and 21 financial audits were selected over the course of the program according to risk-based criteria. The VPA has completed 131 ownership audits and 15 financial audits as of 30 June 2022. The remaining audits have commenced, and on initial assessment have not found cause for concern in relation to compliance. The VPA will report on the outcomes of the remaining audits in a future circular.

Of the audits completed, there were two findings of non-compliance with the Act:

• Year 1 finding: A financial audit of one pharmacy identified the distribution of the profit of a partner to trust beneficiaries not eligible to have a proprietary interest. In this case a panel hearing was convened, and the licensee reprimanded. The licensee had also taken steps to amend the trust to ensure compliance with the Act.
• Year 3 finding: An ownership audit of one pharmacy identified that the ownership arrangement was not consistent with the licence. The director of the company was granted a licence to carry on the pharmacy business as a natural person but failed to apply for a new licence when they switched to a corporate structure. A panel was convened, and the licensee reprimanded.

The VPA plans to continue to undertake pharmacy ownership audits on the basis of notifications or intelligence from its regulatory activities and discontinue auditing on the basis of annual targets. In parallel, the VPA will continue its comprehensive reviews of franchise and other complex commercial agreements to ensure compliance with the ownership and undue influence provisions of the Act.

These initiatives along with the VPA’s comprehensive licence application processes will help detect and deter unlawful pharmacy ownership arrangements.

Update on the VPA Guidelines

The VPA Guidelines have been reformatted to align with and better support the VPA Standards and will come into effect from 1 January 2023. There has been no significant change to the substance or content of the guidelines. The guidelines continue to represent the current policies of the VPA (any departure from them must be justified on a case-by-case basis). They support the VPA Standards and the requirements of the Pharmacy Regulation Act 2010 (the Act). The guidelines are available on the VPA website here.

The guidelines were reformatted to:

• Follow the numbering system of the VPA Standards.
• Align with corresponding standards; the relevant standard has been included in the righthand margin to the respective guideline.
• Remove those guidelines which have been elevated to a standard.
• Remove general information on the role of the VPA, applications for a licence and/or registration of premises, notification processes and the public register of licensees and premises. This information will be added to the VPA website.

The VPA plans to consult with stakeholders in 2023 about revised guidelines to better support licensees and pharmacists to comply with the Act and VPA Standards. Stakeholders are welcome to provide feedback on the current guidelines to assist with the revision process by emailing enquiries@pharmacy.vic.gov.au.

VPA Standards FAQs

The VPA Standards are mandatory requirements for licensees and premises registered by the VPA. Frequently asked questions (FAQs) on the VPA Standards are now available on the VPA’s website here to support licensees that were unable to attend the webinars on the standards.

The FAQs cover key points of the presentation, questions raised by licensees and information, guidance and resources to support compliance with certain standards. These FAQs should be read in conjunction with the Pharmacy Regulation Act 2010, VPA Standards and the VPA Guidelines.

Update on the inspection report and Self-Audit form

Licensees of pharmacies recently inspected by VPA officers will have noted that inspection reports have also been reformatted. Inspection comments are now grouped in categories to distinguish between requirements under the Pharmacy Regulation Act 2010 (the Act), VPA Standards, VPA Guidelines and good pharmacy practice. This change is also consistent with the VPA’s strategic priority to ensure licensees are better supported to engage in good governance and regulatory practice.

The VPA Self-Audit form has also been updated to reflect the introduction of the VPA Standards. The form is designed to assist licensees and employee pharmacists to audit their compliance with key requirements of the Act, the VPA Standards, the VPA Guidelines and good pharmacy practice.

Applications

Update on the provision of approval information to PBS Approved Suppliers

As a courtesy to licensees and with their consent, the VPA has been providing copies of licence and/or registration approval letters directly to the PBS Approved Suppliers Section, Australian Government Department of Health and Aged Care following application approval and the issue of a licence or premises registration. This arrangement was made to ensure the timely receipt of VPA approval information by PBS Approved Suppliers and help facilitate the timely issue of PBS approval numbers.

The VPA understands that PBS Approved Suppliers requires applicants to submit relevant correspondence independently of correspondence forwarded by the VPA. Effective from 1 February 2023, at the request of PBS Approved Suppliers the VPA will cease forwarding correspondence regarding licensing and registration to PBS Approved Suppliers. This process change will avoid duplication of information.

The VPA will continue to request that applicants submit notifications relating to settlement of purchase, commencement of operation or completion of premises by no later than 2.00 pm to facilitate same day processing and issue of licences and/or premises registration.

Quarterly performance report

The VPA's performance measurement framework provides information on its activities and intended outcomes. The quarterly performance report for the period 1 July 2022 to 30 September 2022 is available on the VPA website.

From the inspectors

The guidance information contained in the following sections is 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.

A focus on managing S8 poisons

The licensee is 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 Schedule 8 (S8) poisons.

The management of S8 poisons is a high-risk area posing a significant risk to public safety and significant non-compliance may result in a panel hearing.

Licensees should consider the follow points and take necessary actions where the answer is in the negative. These are areas that often come up in inspections.

• Are all S8 poisons stored in a drug safe?
• Does your existing drug safe have the capacity to store all S8 poisons, including but not limited to returned S8 poisons and those used to pack dose administration aids?
• Is your drug safe used exclusively for the storage of S8 poisons, S9 poisons or drugs of dependence?
• Is your drug safe constructed and secured in accordance with regulation 74 of the Drugs, Poisons and Controlled Substances Regulation 2017 and Medicines and Poisons Regulation (MPR), Department of Health’s guidance document Management of Schedule 8 poisons?
• Is the key/code to the drug safe held and controlled by a registered pharmacist to prevent unauthorised access? The drug safe must remain locked and secured at all times except when it is necessary to open it to carry out an essential operation in connection with the S8 poisons. Drug safe keys cannot be left in the door of the drug safe or keep it in a hidden location of the pharmacy during and outside business hours where it might be located by persons other than pharmacists.
• Are all S8 poisons transactions entered into the drug register as soon as practicable i.e., immediately after the transaction but no later than the same day of the transaction?
• Is the balance of the drug register checked against the actual stock after each transaction to ensure the drug register reflects true and accurate balances?
• Are regular S8 poisons stock checks scheduled to confirm the balance of all S8 poisons?
• Are discrepancies in S8 poisons investigated without delay and any unresolved discrepancies reported promptly to MPR at dpcs@health.vic.gov.au?
• Are returned S8 poisons recorded in the drug register e.g., in a designated section of the drug register to record drugs for destruction?
• Are regular sessions scheduled to destroy returned or expired S8 poisons to avoid the build-up of unwanted S8 poisons and maximise usable space in the drug safe?
• Does the pharmacy have a S8 management procedure that is clearly documented, easily accessible, regularly reviewed and updated as part of effective governance arrangements? Is the procedure readily available to all pharmacists and are being followed?

Licensees may wish to refer to the Resource section of this circular for resources on S8 management.

Did you know?

Installation of automatic machines in pharmacies

Interstate pharmacy premises regulators have informed the VPA about recent enquiries from pharmacists wanting to install an automatic machine into the front of a pharmacy so that a person can collect dispensed medicines using a PIN or other security measures. The VPA is also aware of recent advertising in pharmacy media about automatic machines for this or similar purposes.

Licensees considering the installation of an automatic machine in a pharmacy should note that section 30 of the Drugs, Poisons and Controlled Substances Act 1981 does not allow for the installation or sale or supply of any poison or controlled substances by means of any automatic machine. A poison or controlled substance is any scheduled substance listed in the Poisons Standard.

Under section 21 of the Therapeutic Goods (Victoria) Act 2010, a person must not install a vending machine or supply therapeutic goods via a vending machine without the written consent of the Victorian Secretary to the Department of Health. The department advises that approvals cannot be granted for scheduled substances. General approvals have been granted for a limited range of therapeutic goods, such as condoms, sunscreens and unscheduled medicines in limited quantities. For further information please contact Medicines and Poisons Regulation, Department of Health via email dpcs@health.vic.gov.au.

It is also important to note that VPA Standard 2.2.1 requires licensees to obtain VPA approval prior to making any significant alteration to registered premises. Alterations to the perimeter (or perimeter security) of registered premises are significant alterations under the VPA Guidelines. This means VPA approval is required for the installation of any machine or similar (including automatic teller machines) into the perimeter of a pharmacy.

Licensees may contact the VPA at enquiries@pharmacy.vic.gov.au if further clarification is required.

For information

AHPRA registration renewal – implications of lapsed registration for owners

Registered pharmacists need to renew their AHPRA registration annually. Pharmacists who do not apply to renew their registration with AHPRA by 31 December 2022 (end of late period) will have lapsed registration and will not be able to practise.

A pharmacist licensee whose registration lapses is no longer eligible to own or have a proprietary interest in a pharmacy business and the licence may be revoked. If the registration of a pharmacist director or shareholder of a company licensee lapses, the VPA may revoke the company licence.

Pharmacists are reminded to check their registration status and renew their registration as a matter of urgency. Pharmacists can check their registration details and expiry date on the national register of practitioners.

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