In this Circular

Chair's message

Welcome to the VPA’s first circular for 2023.

The VPA recently conducted targeted inspections of pharmacies dispensing high volumes of medicinal cannabis in collaboration with Medicines and Poisons Regulation branch, Department of Health. Key observations are highlighted in this circular. This area will remain an area of focus for the VPA.

An online survey is now available for licensees and pharmacists to provide feedback following an inspection as part of the VPA’s commitment to improving its processes and internal training.

There is a reminder from VPA inspectors to check that the premises has a current and complete set of reference texts and that the pharmacy is ready to meet the increased vaccination workload in the coming months. The circular also includes a summary of recent panel hearings.

I would like to take this opportunity to thank Connie Greco for her hard work and significant contributions to the VPA as a Program Officer and inspector. Connie was with the VPA since its inception in 2010 and prior to that she was the Education Officer for the Pharmacy Board of Victoria. She will be greatly missed and we wish her all the best in her next endeavours.

David McConville
Chair

Special focus

Medicinal cannabis

Medicinal cannabis is a current focus area of the VPA given the rapid increase in the number of Victorian pharmacies involved and the high volumes of medicinal cannabis handled.

Officers of the VPA recently conducted targeted inspections of pharmacies dispensing high volumes of medicinal cannabis with officers of the Department of Health, Medicines and Poisons Regulation branch. VPA inspectors noted there has been a rapid expansion of medicinal cannabis supplied by pharmacies and the following compliance matters were documented:

• Insufficient number of dispensing stations given prescription volumes
• Inadequate space in drug safes to store the expanding range of products
• S8 safes installed without motion sensor coverage
• Medicinal cannabis awaiting collection or delivery, left outside the dispensary
• S8 medicinal cannabis records made by a person other than a registered pharmacist
• S8 medicinal cannabis records not made at the time of dispensing and in some cases made several days later
• In some instances, pharmacists did not verify that the prescription was written by the purported prescriber
• Counselling provided by nurses, or other third-party arrangements, and not a registered pharmacist from the pharmacy providing the service
• Software lists (SKUs) not up to date with new medicinal cannabis products
• Significant alterations to the premises without prior approval from the VPA

Proprietors and pharmacists should assess whether current practices meet legislative requirements in relation to S8 storage, recording and dispensing; requirements of the VPA Standards and VPA Guidelines; the Pharmacy Board of Australia’s Guidelines and code of conduct and good pharmacy practice.

The VPA also wishes to highlight environmental considerations around odour and ventilation associated with medicinal cannabis products as the comfort or amenity of pharmacy staff and clients, in addition to people outside the pharmacy, may be affected.  Consideration should be given to extraction fans, charcoal and/or HEPA based filters, or other means of air purification in areas where odour from medicinal cannabis products may be an issue. Licensees may need to seek independent expert advice in relation to this.

The VPA continues to engage with stakeholders in relation to risks associated with medicinal cannabis in pharmacies.

Inspection feedback

The VPA’s risk-based inspection program monitors compliance and supports licensees to understand and comply with the Pharmacy Regulation Act 2010, the VPA Standards, the VPA Guidelines and good pharmacy practice. It is central to ensuring public safety and the VPA’s strategic priority that licensees be better supported to engage in good governance and regulatory practice.

Licensees and pharmacists are invited to provide feedback on the process and communication of inspections undertaken by the VPA following an inspection. A link to the online inspection feedback form is now included in VPA letters accompanying inspection reports. The information received may be used to review processes and for internal training purposes.

Farewell Connie Greco

It is with sadness that the VPA informs stakeholders of the recent resignation of Connie Greco, Program Officer - Licensing and Registration.

Many pharmacists and stakeholders would be familiar with Connie as the primary contact for VPA licence and registration applications in recent years. Connie was also an experienced VPA inspector and was previously the Education Officer with the former Pharmacy Board of Victoria for many years. She will be greatly missed by VPA members, staff and stakeholders.

We know that stakeholders will join us in thanking Connie for her significant contributions and hard work over many years and we wish her well in her career and future endeavours.

The recruitment process for a new Program Officer is underway. In the interim, the VPA is fortunate to have a team of experienced pharmacists and staff to ensure the continued efficient assessment of applications.

Applications

Current versions of application forms

Application forms are updated periodically. Applicants and their representatives are advised to always use the current version on the VPA website rather than saved copies to avoid delays from having to resubmit the correct version.

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.

Do you have access to a current and complete list of reference texts?

VPA Standard 1.2.6 states that the licensee shall provide for the appropriate management of the pharmacy business, pharmacy department or pharmacy depot by ensuring that staff have access to current reference texts. This includes any essential references specified by the Pharmacy Board of Australia: Guidelines on practice specific issues – Guideline 1 (List of reference texts for pharmacists). This guideline was amended on 15 March 2023 to include changes to the titles of currently available reference texts, and Appendix A lists the minor amendments made.

According to the Pharmacy Board of Australia, access to contemporary references is essential to the practice of pharmacy. Licensees should have a procedure in place to ensure that references are always current and readily accessible, for example:

• reminders of when subscriptions are due for renewal or when a new edition is due to be released in the case of hard copies;
• implementing scheduled checks for currency and completeness of the reference library against the Guideline; and
• providing all pharmacists with the login details to electronic references e.g., locum pharmacists.

Licensees are also strongly encouraged to evaluate whether additional references beyond the mandated list should be available to support the delivery of specific pharmacy services such as complex compounding.

Vaccination readiness

Pharmacies are likely to vaccinate more in the coming months with the uptake of the flu vaccine.

Inspectors have found in recent inspections:

• Instances of expired adrenaline ampoules in anaphylaxis response kits. Pharmacists should schedule regular checks to ensure that the kit contains all the items specified in the Victorian Pharmacist-Administered Vaccination Guidelines and is readily accessible to the pharmacist immuniser.
• Some pharmacist immunisers did not have a current first aid and CPR certificate which is a condition of the Secretary Approval. First aid certificates are valid for 3 years while CPR certificates require an annual renewal. A second staff member must also have a current first aid and CPR certificate and be present in the pharmacy while the pharmacist immuniser is vaccinating and for 15 minutes afterwards. The licensee is responsible for ensuring that all staff are suitably qualified and trained in accordance with VPA Standard 1.2.3. In relation to vaccination, licensees may find it helpful to keep a record of what training has been completed and when they are due for renewal.

As vaccination workload is likely to increase in the coming months, licensees should review the pharmacy workload and implement measures to ensure that the pharmacy is adequately staffed for the safe and effective provision of pharmacy services:

• Is there enough staff given the overall pharmacy workload? Does the pharmacy need additional staff or should pharmacy services be scaled back?
• Should vaccination services be provided on certain days or times of the week when there is enough staff on duty?
• Can a sole pharmacist safely and effectively provide vaccination services in light of the workload, staffing, foot traffic and pharmacy processes unique to the pharmacy?

Pharmacists are encouraged to refer to the circular item A focus on vaccination services from Circular No. 30 – 24 November 2022 for further guidance.

Did you know?

Who can prepare and administer the COVID-19 vaccines?

A time-limited approval, Secretary Approval: Pharmacist Immuniser – SARS COV-2 (Covid-19) VACCINE authorises pharmacist immunisers to prepare and administer COVID-19 vaccine in accordance with the conditions outlined in the approval until 19 October 2023 inclusive, unless revoked earlier.

Public Health Emergency Order (PHEO #8): Authorisation for preparation and administration – COVID-19 Vaccine has been extended with amendments to authorise registered pharmacists to prepare and administer COVID-19 vaccines and pharmacy technicians to prepare COVID-19 vaccines in accordance with the conditions listed in the Order. A further amendment withdraws authorisation for pharmacy students and interns registered with Ahpra as part of the emergency/surge workforce. PHEO#8 is in force from 21 February 2023 to 20 August 2023 inclusive, unless revoked earlier, and is an amendment and extension of the Order issued on 7 July 2022.

Recent panel hearings

The VPA held ten panel hearings between November to December 2022 into allegations that licensees had failed to meet their responsibilities to comply with the Pharmacy Regulation Act 2010 (the Act) and the VPA Standards at registered premises. Nine panel hearings resulted in licensees being reprimanded, while in one case the licensee was cautioned.

A summary of a selection of hearings follows:

Case 1
The licensee had allowed a staff member who was not a registered pharmacist to have access to the pharmacy when it was not open for business and when a registered pharmacist was not present. The keys to the S8 drug safe were kept in an unlocked draw known to the staff member. It was also observed that the premises was not constructed in accordance with the application for registration of the premises e.g., the dispensary and prescription reception and counselling area were not as per the agreed plan.

There were security concerns that the dispensary and drug safe were not covered by a 24-hour monitored intrusion detector alarm and that the roof was not constructed in a manner to prevent unauthorised access.

The dispensary was not dedicated to the dispensing of medicines and associated tasks. The point of sale computer was in the dispensary and the dispensary was used for general administrative activities. There were other deficiencies relating to privacy of records, cold chain management and good pharmacy practice.

The licensee was reprimanded and conditions imposed on the registration of the pharmacy premises requiring an unannounced re-inspection of the pharmacy to be undertaken at the licensee’s cost and for the licensee to conduct an audit of the pharmacy at least quarterly.

Lessons for licensees

• Personal supervision and access to the pharmacy: Section 31(1) of the Act states that the registered pharmacist who is regularly and usually in charge of a pharmacy and the person licensed to carry on the pharmacy business must not allow a person to have access to that pharmacy when it is not open for business unless a registered pharmacist is present. This offence is subject to 60 penalty units. The same applies for a pharmacy department under section 31(2) of the Act.

[Licensees should also be aware of the requirement that pharmacies must be personally supervised by a registered pharmacist at all times they are open for business (section 30 of the Act)]

• Access to S8 poisons: Standard 1.1.3 of the VPA Standards states that the licensee is responsible for ensuring that all medicines and poisons are managed in accordance with legislation and good pharmacy practice. S8 safe keys should be kept on the person of a pharmacist or otherwise secured in a key safe to which pharmacists have exclusive access as per VPA Guidelines G2.4.2.2.
• Registration of premises application: Pharmacy premises are expected to be constructed according to the plans that the VPA has agreed to in principle. If, due to technical or other reasons, the plans that are ‘agreed to in principle’ need to be altered during construction, the VPA office should be contacted for advice. The premises must conform to the application and the requirements of the Act in order for the VPA to finalise the registration of the premises following an on-site assessment.
• Security: Standard 2.3.3b of the VPA Standards requires registered premises to be fitted with a functional, 24-hour monitored intrusion detector alarm which covers all areas where medicines and poisons are kept. In this case the dispensary and the S8 drug safe were not covered. The ceiling was not substantially constructed and secured to prevent unauthorised access as required by VPA Standard 2.3.1.
• Dedicated dispensary: Standard 2.4.1 of the VPA Standards states that the dispensary shall be a private area, dedicated to tasks associated with the dispensing, supply and compounding of medicines and secure storage of medicines and patient records. General administrative activities (e.g., preparing price labels and signs and data entry) should be undertaken in a separate area away from the dispensary.

Case 2
A company licensee is required to notify the Authority within 14 days of a change to the shareholding, directorship and office bearers of the company in accordance with section 27 of the Act. In this case, the company had a new director, secretary and shareholder but failed to notify the VPA.

The Panel made the decision to reprimand the licensee because the failure to notify the VPA within 14 days of a change to the directorship and office bearers of the company licensee constitutes a breach of the Act for which the company licensee could have been prosecuted.

For information

New emergency instruction regulations

From 31 March 2023, new regulations in the Drugs, Poisons and Controlled Substances Regulations 2017 enable a prescriber to transmit a digital image of an original prescription to a pharmacist to enable supply of a Schedule 4 or 8 medicine in an emergency. The new regulations implement a defined timeline (72 hours) when the prescriber must send the original paper prescription to the pharmacist after transmitting the digital image or following a verbal instruction to a pharmacist to instruct supply in an emergency.

For more information, refer to:

• Medicines and Poisons Regulation guidance document New emergency instruction regulations to facilitate pharmacist supply of medicines in an emergency
• Drugs, Poisons and Controlled Substances Regulations 2017, regulation 25A Emergency transmission of digital image to pharmacists regarding supply

Updates to the Victorian Department of Health’s seasonal influenza vaccine website

The department’s seasonal Influenza vaccine website has been updated to reflect 2023 influenza vaccination information and will be regularly updated. It includes links to clinical resources and advice, an eLearning module and guidance to support immunisation providers with the requirements of the influenza program.

The website also includes a link to the Australian Technical Advisory Group on Immunisation’s (ATAGI) advice on seasonal influenza vaccines in 2023.

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