In this Circular

Chair's message

This circular includes information to remind stakeholders about the VPA’s approach to licence applications involving new and complex commercial arrangements; a part of the way we ensure that all Victorian pharmacies are owned, operated, and controlled only by registered pharmacists. There is also an update on improvements to the inspection program.

Licensees are reminded of standard conditions on all licences requiring them to notify the VPA of proposed changes to pharmacy commercial arrangements, and of distributions made to a beneficiary under a pharmacy trust arrangement.

VPA inspectors encourage licensees and pharmacists to review their dose administration aid procedures to ensure they comply with the Pharmacy Board of Australia’s Guidelines on dose administration aids and staged supply of dispensed medicines. There are also key lessons for licensees from recent panel hearings, including the risks high workloads pose for patient safety.

I am also pleased to share that the Pharmacy services self-audit tool: Immunisation site readiness is now available to assist pharmacies that offer immunisation services to meet their obligations and support good pharmacy practice. This self-audit tool was codesigned by the VPA and Victorian Department of Health.

David McConville
Chair

Special focus

VPA’s approach to licence applications involving new and complex commercial arrangements

The VPA is committed to ensuring that all Victorian pharmacies are owned, operated and controlled only by registered pharmacists in accordance with the Pharmacy Regulation Act 2010 (the Act).

When negotiating and entering into a franchise agreement or related commercial agreement, it is very important to be aware of the undue influence provisions of the Act. The Act places restrictions on who can control or influence the way in which a pharmacy business is carried on.

Section 11 of the Act (Undue influence) prevents any person other than the person licenced to carry on the pharmacy business from having:

a) the right to control the manner in which the pharmacy business is carried on; or
b) the right to access books of accounts or records kept in respect of that business, otherwise than for the purpose of determining whether or not the conditions of the relevant document are being complied with; or
c) the right to receive any consideration that varies according to the profits or takings of the business.

The VPA must be satisfied that proposed ownership and commercial arrangements are compliant with the Act before granting a licence to a person to carry on a pharmacy business.

Applications involving agreements which are new to the VPA (i.e., where a detailed review has not yet been completed by the VPA) and complex agreements or ownership structures are routinely referred to the VPA’s external lawyers for a detailed assessment of compliance with the Act. These reviews have identified several cases where franchise or related agreements gave a third party the right to control aspects of the operation of the pharmacy business.

In such cases, the VPA writes to applicants outlining areas of potential non-compliance. Amendments may then be negotiated and made to the extent that the VPA can be satisfied that the agreements do not contravene the Act. The VPA encourages applicants and franchisors to engage collaboratively in this review process to avoid delays.

It is important to note that:

• The VPA does not have a position concerning pharmacy franchising. The VPA is committed to ensuring that pharmacy franchise agreements do not offend the ownership or undue influence provisions of the Act.
• Applicants are encouraged to seek independent advice regarding compliance of proposed structures and commercial agreements. The VPA cannot provide legal advice to applicants or stakeholders.
• The VPA publishes commercial arrangement guidance on its website to assist stakeholders to ensure that pharmacy business commercial arrangements comply with the Act. For example, the VPA’s guidance on franchising provides examples of the types of clauses that pharmacists should be wary of and avoid. The VPA plans to review and publish updated guidance soon.
• In the case of agreements previously reviewed by the VPA, franchisors are encouraged to provide documents in a format which clearly identifies any changes to the agreements to help facilitate their assessment. Nevertheless, all applications and commercial agreements are assessed on a case-by-case basis considering the facts and circumstances of each application.
• Applications are a confidential process between applicants and the VPA. Information about applications and their assessment can only be disclosed to an applicant or their authorised representative.

Update on the VPA inspection program

We are making changes to improve how we focus our inspection efforts according to risk. This includes better targeting of inspections and making compliance with the VPA Standards and other high-risk areas the primary focus of inspections.

Licensees will be aware that inspection reports issued over the last 9 months have been formatted to distinguish mandatory requirements under the Act and the VPA Standards from other requirements relating to good pharmacy practice. The premises self-audit form was also updated to reflect requirements under the standards.

Over the coming months, we aim to:

• increase our focus on the VPA Standards during inspections
• further improve the self-audit form to highlight areas of focus in inspections to support ongoing compliance, and
• implement processes to give licensees more opportunities to self-audit their compliance in areas related to good pharmacy practice.

Further information will be provided in future communications.

Pharmacy services self-audit tool: Immunisation site readiness

The VPA and Victorian Department of Health have codesigned the Pharmacy services self-audit tool: Immunisation site readiness to assist licensees and pharmacist immunisers who offer immunisation services at the pharmacy to undertake a compliance assessment. The tool focuses on site readiness and key aspects of the Victorian Pharmacist-Administered Vaccination Program.

The department and the VPA recommends:

• that new pharmacy immunisation service providers complete the self-audit tool to assess compliance, prior to commencing immunisation services; and
• pharmacies that provide immunisation services complete the tool at least annually to demonstrate ongoing compliance and promote best practice.

Following the audit, pharmacies should review the findings and identify opportunities for improvement. Pharmacies should retain the most recently completed self-audit to demonstrate compliance and provide upon request to the VPA or the department.

Applications

Supervision

Applicants applying to register new or alter existing pharmacy premises should evaluate whether the design of the pharmacy complies with the supervision requirements of the Schedule to the Pharmacy Regulation Act 2010:

• Clause 4: There is no access to the dispensary of the pharmacy except under the direct supervision of a registered pharmacist.
• Clause 7: A registered pharmacist must oversee the area of the pharmacy where pharmacy services are provided.

An enclosed dispensary with minimal visibility into or out of the dispensary is unlikely to satisfy these requirements. Consideration should be given to the positioning of robotic dispensing systems to ensure supervision is not compromised. The VPA assesses all applications on a case-by-case basis. Any applications that do not appear to comply with VPA requirements will be referred to a monthly meeting for consideration by Authority members.

Schedule of Fees

The VPA fixed the fees for a period of 12 months commencing 1 May 2023 pursuant to section 104 of the Pharmacy Regulation Act 2010. The Schedule of Fees 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 reminder about dose administration aids (DAAs)

Inspectors highlight the following areas:

Filling area

• If the pharmacy regularly fills DAAs for 15 or more persons per week, the dispensary should include a bench of at least one square meter dedicated to the filling of DAAs (VPA Guidelines, G2.4.2.2).
• It should be clean, tidy, and orderly and free from interruption to minimise the risk of errors and to ensure good hygiene practices.
• DAA filling rooms that are located away from the dispensary must be locked when not in use.
• Where the pharmacy uses a DAA packing machine, there is to be a cleaning and maintenance protocol.

DAA packing records

• A record of each packing into a DAA should be made with the details outlined in the Pharmacy Board of Australia’s Guidelines on dose administration aids and staged supply of dispensed medicines. There should also be a record of any changes made to a DAA (e.g., addition of medicines or where there are changes to the medication regimen).

Packing by a third party (TGA licensed facility or another pharmacy)

• It is the packing pharmacist’s responsibility to ensure that DAAs are prepared accurately according to the patient’s current medication regimen.
• The supply pharmacist (who supplies the DAA to the patient or their agent) is required to assess the measures, techniques and technology used by the packing pharmacists to check packed DAAs for accuracy and to determine whether additional checking of a DAA is required prior to its supply.

DAA labels and storage:

• DAA dosing instructions should be in plain English and not Latin. Cautionary advisory label 1 is to be applied directly to the DAA if the packed medicine can cause drowsiness, and any additional cautionary advisory information should be communicated to the patient on a routine basis.
• Dispensed S8 poisons used for DAA packing and DAAs containing S8 poisons are to be stored in a drug safe. DAAs containing S4 poisons should be stored in the dispensary or in a lockable storage facility.

Pharmacists should refer to the following resources for further guidance

• Pharmacy Board of Australia’s Guidelines on dose administration aids and staged supply of dispensed medicines here
• Pharmaceutical Society of Australia’s Guidelines for pharmacists providing dose administration aid services here

Pseudoephedrine products – out of sight and out of reach

Pseudoephedrine is used as a precursor in the illicit manufacture of amphetamines. Licensees are reminded that all stocks of medicines containing pseudoephedrine should be kept out of view of the public (VPA Guidelines, G1.1.3).

According to the Pharmacy Board of Australia’s Guidelines on practice-specific issues:

• Pseudoephedrine stock levels should be minimal in accordance with the sales history of the pharmacy and relevant security issues.
• Bulk supplies should be avoided and any reserve stock kept out of public view.

The Drugs, Poisons and Controlled Substances Regulations 2017 also places restrictions on the storage and display of S3 poisons whereby they must not be kept, stored, or displayed in a manner which readily allows self-selection by the public.

Did you know?

Notification: changes to commercial arrangements

It is a condition of all licences that the licensee must inform the VPA of any changes to the commercial arrangements to which a pharmacy business is conducted or proposed to be conducted prior to those changes taking effect.

This enables the VPA to review whether the proposed changes to the commercial arrangements are compliant with the ownership and undue influence provision of the Pharmacy Regulation Act 2010.

The VP31 form Notification of a change to commercial arrangements for a pharmacy business should be used to notify the VPA when a pharmacy business changes an existing arrangement or enters into any new commercial arrangements relating to that business, for example, but not limited to:

• changes to partnership agreements or composition of partners;
• agreements with third parties such as licence agreements, franchise agreements, management/marketing/service agreements; and
• pharmacy trust deeds.

Notification: distribution made to a beneficiary under a pharmacy trust

It is a condition of all licences that where a trust is involved in the ownership of the pharmacy business or any proprietary interest in the pharmacy business is held pursuant to a discretionary trust, the licensee must inform the VPA of any distribution made to a beneficiary under the trust, within 14 days of such distribution occurring.

The VP31 form Notification of a change to commercial arrangements for a pharmacy business should be used to notify the VPA of the distribution.

Recent panel hearings

The VPA held nine panel hearings between January to April 2023 into allegations that licensees failed to meet their responsibilities to comply with the Pharmacy Regulation Act 2010 (the Act) and VPA Standards. Five panel hearings resulted in licensees being reprimanded, while there were four cases where the licensees were cautioned.

A summary of a selection of hearings follows:

Case 1
The licensees failed to obtain VPA approval prior to making significant alterations to the registered premises as required by standard 2.2.1 of the VPA Standards. Alterations were made to the dispensary resulting in a thoroughfare through the dispensary for staff needing to access the bathroom and storeroom facilities. An existing vaccination room was also used as a dose administration aid (DAA) filling room. Schedule 4 poisons for DAAs were stored on open shelves and benches in the room rather than a lockable storage facility and were potentially accessible to clients receiving vaccinations. Further, patient DAA records were not kept confidential or secure under this arrangement.

Key lessons:

• Significant alterations are described in the VPA Guidelines, G2.2.1. By approving significant alterations to registered premises, the VPA can ensure that the premises remain suitable and do not present a risk to public safety. Licensees may wish to contact the VPA to clarify whether planned alterations require an application.
• The pharmacy should be designed so that the dispensary is not used as a thoroughfare to access “back of house” areas (VPA Guidelines, G2.4.1). This is because the dispensary is to be maintained as a private area, dedicated to tasks associated with the dispensing, supply and compounding of medicines and secure storage of medicines and patient records.
• A dual-purpose room for DAA filling and vaccination is not acceptable. Schedule 4 poisons must be stored in the dispensary or in a lockable storage facility pursuant to regulation 73 of the Drugs, Poisons and Controlled Substances Regulations 2017. A lockable storage facility must remain locked and secured to prevent access by a person that is not a pharmacist except when it is necessary to open it to carry out an essential operation in connection with poisons stored in it.

Numerous expired or returned S8 poisons were stored in a box on the floor of the dispensary and many S8 transactions were not recorded in the drug register. The licensee failed to ensure that all medicines and poisons are managed in accordance with legislation and good pharmacy practice (standard 1.1.3 of the VPA Standards).

Key lessons:

• S8 poisons must be stored in the S8 drug safe including expired or returned S8 poisons. They should be quarantined separately from the S8 stock on hand to ensure that they are not inadvertently dispensed to a patient. Pharmacists should schedule regular destruction sessions to avoid the build-up of unwanted S8 poisons.
• Pharmacists must ensure that the records of all transactions in S8 poisons show the true and accurate balance after each transaction by confirming the balance on hand. Non-compliant storage and recording of S8 poisons increases the risk of misappropriation and poses a risk to public safety.

The licensees failed to install a motion sensor covering the new S8 drug safes and in the room used for DAA filling. The drug refrigerator was not dedicated to the storage of medicines (it was also used to store staff food and drinks) and adequate cold chain temperature monitoring did not occur. There were also other issues identified in relation to clutter and good pharmacy practice.

Key lessons:

• VPA Standard 2.3.3 requires a functional 24-hour monitored intrusion detector alarm to cover all areas where medicines and poisons are kept.
• VPA Standard 2.4.2(b) requires the dispensary to be fitted with refrigeration which is dedicated to and appropriate for the storage of medicines, with adequate temperature monitoring. The National Vaccine Storage Guidelines ‘Strive for 5’ requires information from the data logger to be downloaded at least weekly for review in addition to the manual recording of twice-daily minimum and maximum temperatures as a timely alert to any breach in the cold chain.

The licensee was reprimanded, and conditions were imposed on the registration of the pharmacy premises requiring the licensees to undergo an unannounced re-inspection at their cost and an application for approval of the alterations to be submitted to the VPA.

Case 2
The licensees had shown ongoing non-compliance in relation to:

• Workload (standard 1.2.4): The pharmacy was regularly supervised by a sole pharmacist. The dispensing workload exceeded the level provided by the guidelines. The pharmacy also services many DAA patients while also providing pharmacotherapy and vaccination services.
• Cold chain management (standard 2.4.2(b)): The drug refrigerator was used to store staff drinks and adequate cold chain temperature monitoring did not occur.
• Dedicated use of the dispensary (standard 2.4.1): Dispensary benches and floor area were cluttered with retail goods, paperwork and other items not related to the dispensing of medicines.

A filing cabinet was used to store S8 poisons rather than a drug safe that is compliant with the Drugs, Poisons and Controlled Substances Regulations 2017. There were other instances of non-compliance with VPA Standards and good pharmacy practice.

The licensees were reprimanded, and conditions were imposed on the licences prohibiting the licensees from permitting anyone at the premises to administer any vaccination and pack DAAs. The conditions were subsequently removed at the discretion of the VPA when it was reasonably satisfied that adequate, suitably qualified, and trained staff had been engaged or employed to support service demands and to ensure the safe and effective provision of pharmacy services.

Lessons for licensees:

• Standard 1.2.4 of the VPA Standards states that the licensee shall provide for the appropriate management of the pharmacy business by ensuring that there are enough suitably qualified and trained staff to support service demands and the safe and effective provision of pharmacy services. The sustained high pharmacist workload at the pharmacy was not consistent with public safety, notably the pharmacist dispensing levels also significantly exceeded recommended levels as set out in the Pharmacy Board of Australia’s Guidelines for dispensing of medicines.

For information

Dextromethorphan abuse and misuse

A local community support service has advised that there is prevalence of dextromethorphan misuse and abuse in the Geelong region.

Licensees are reminded that clause 9(d) of the Schedule to the Pharmacy Regulation Act 2010 requires that adequate arrangements are in place to ensure that the sale of medicines particularly those known to be abused or misused are supervised and monitored.

The Pharmacy Board of Australia’s Guidelines on practice specific-issues also states that:

• As part of their continuing professional development, pharmacists are expected to have a contemporary knowledge of the drugs that are subject to abuse or misuse, both generally and in their own localities.
• A genuine therapeutic need is to be established by careful questioning.
• That only one proprietary pack of Pharmacy Medicines should be supplied at a time unless there are exceptional circumstances clearly demonstrable by the customer, additional documentation of which should be kept.
• Caution should be exercised when considering requests for supply of multiple packs, particularly for drugs subject to abuse or misuse.

Opioid Dependence Treatment Program and Schedule 8 records

The Opioid Dependence Treatment (ODT) Program commenced on 1 July 2023. Information about the program is available on the PBS website.

The Drugs, Poisons and Controlled Substances Regulations 2017 requires that records of all transactions in respect of methadone or buprenorphine are made at least daily if the transaction is for the purposes of opioid replacement therapy. Supplies of methadone or buprenorphine for ODT must be entered into the S8 drug register when they occur. This should not be confused with the dispensed quantity available on an ODT prescription which stipulates the number of doses available to a patient rather than the quantity supplied on a given day.

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