In this Circular
From the inspectors
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For information
Resources |
Chair's message
Welcome to the Authority’s April circular.
An important subject I would like to highlight in this circular is that the Authority expects to publish Standards very soon. Complying with the Standards will be mandatory for Victorian pharmacies, pharmacy businesses and pharmacy departments.
Meeting the requirements of the Standards should not present a new challenge for licensees or require significant expenditure because they are drawn from existing guidelines and legislation.
The Standards have 2 overarching principles, which are:
- The licensee is responsible for the delivery of pharmacy services that, through appropriate governance and oversight, are consistent with the law and good pharmacy practice. Public safety is paramount and the risk of causing harm must always be considered as part of the delivery of pharmacy services.
- The design, condition, facilities, and security of registered premises provide an appropriate environment for the safe custody of medicines and poisons and provision of pharmacy services.
Once published, I encourage all licensees and their staff to familiarise themselves with the Standards. I look forward to engaging with licensees and industry stakeholders as the VPA promotes the introduction of the Standards in the months ahead.
David McConville
Chair
Special focus
Preparing for the Victorian Pharmacy Authority Standards
As advised in previous communications, the Authority is in the process of issuing standards.
The Victorian Pharmacy Authority Standards (the Standards) have been approved by the Minister for Health. The Authority will announce the commencement of the Standards in a separate communication shortly. They will be published in the Government Gazette and on the VPA website as required by the Pharmacy Regulation Act 2010 (the Act). The Standards will take effect on the day they are published in the Government Gazette.
The Standards will be mandatory requirements for Victorian pharmacies, pharmacy businesses and pharmacy departments.
The Standards are drawn from the Act, the existing Guidelines and other legislative requirements; they do not include new or additional requirements. Consequently, complying with the Standards should not present a new challenge for licensees or require significant expenditure.
The Standards will be a focus of pharmacy inspections and licensees are encouraged to review their procedures in relation to the following requirements of the proposed Standards:
Licensee responsibilities
- Ensuring that there are enough suitably qualified and trained staff to support service demands and the safe and effective provision of pharmacy services
- Ensuring that records for Schedule 8 and 9 poisons are in accordance with drugs and poisons legislation
- Ensuring that staff have access to current reference texts
Premises
- Registered premises shall comply with relevant requirements of the Schedule to the Act on an ongoing basis [The Act can be viewed here]
- Registered premises shall be maintained in an organised, uncluttered state
- 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
- The dispensary shall be fitted with a dedicated storage facility for Schedule 8 and 9 poisons which complies with legislation, provides adequate storage for poisons on hand at all times and facilitates their accurate selection
- Equipment [including weighing equipment] shall undergo regular maintenance, including routine calibration or servicing
- There shall be a range of current reference texts relevant to the pharmacy services provided, at the premises
The Authority plans to revise its Guidelines to ensure they support the Standards and continue to assist licensees to comply with the Act. The Authority also plans to support compliance with the Standards by hosting a forum/webinar or similar in the future.
Quarterly performance report
The Authority's performance measurement framework provides information on its activities and intended outcomes. The quarterly performance report for the period 1 October 2021 to 31 December 2021 is available on the VPA website.
Amendments to the Pharmacy Regulation Act 2010
The Pharmacy Regulation Act 2010 (the Act) has been amended in accordance with the Regulatory Legislation Amendment (Reform) Act 2022, which commenced on 30 March 2022.
The amendments provide for:
- late lodgement of applications for renewal of licences and registrations; and
- inspections to be carried out, and panel hearings and Authority meetings to be held, by audio visual link.
The current version (Version 9) of the Act can be viewed here.
Pharmacy workload
When additional pharmacy services are introduced, such as vaccinations and dose administration aids, licensees should closely monitor the overall workload of the pharmacy, including in relation to dispensing prescriptions, supervising the pharmacy, providing primary health care and other pharmacy services.
The VPA Guidelines on Workloads in community pharmacies (4.3.10.1) provide guidance on minimum staffing levels for dispensing. They complement the Pharmacy Board of Australia’s Guidelines for dispensing of medicines, setting expectations for staffing levels when daily prescription numbers are in the order of 150-200, and provide additional detail on the Authority’s expectations when dispensing workload exceeds 200 prescriptions per day.
The workload guidelines should be used as a benchmark, and the Authority wishes to highlight the following key points to pharmacists:
- Sustainable workload may also be affected by other factors such as dispensing technologies, staff familiarity with systems and other non-dispensing responsibilities.
- The preparation of each take-away dose of methadone or buprenorphine and each administration of either drug is counted as being the equivalent of one prescription.
- Consideration should also be given to the time taken to undertake non-dispensing tasks, for example checking dose administration aids and immunisation.
While the guidelines set a number of prescriptions dispensed per day as a baseline, the Authority and its inspectors consider a range of factors when evaluating dispensing workload. Inspections have revealed that, while overall staff may meet the requirements of the guidelines, some dispensary staff are engaged in activities other than dispensing such as preparing dose administration aids and administering vaccinations. Licensees are required to monitor workloads to ensure there is sufficient staff actually engaged in dispensing to satisfy the requirements of the dispensing workload guideline.
Changing pharmacy business commercial arrangements
The Authority is aware of recent reports of changes to the commercial landscape in the pharmacy industry and reminds licensees of the requirement to inform the Authority about proposed changes to pharmacy business commercial arrangements prior to those changes taking effect. This is a condition of all licences.
Such changes include but are not limited to changes involving new or altered:
- Trust arrangements
- Service agreements
- Franchise agreements
- Intellectual Property Licence Agreements
- Partnership agreements
- Loan and security agreements
- Leases
A VP31 Notification of a change to commercial arrangements for a pharmacy business form is available to download from the VPA website for this purpose.
Geoff McCurdy retires
VPA inspectors visit pharmacies and pharmacy departments to monitor compliance with the Act and support licensees to understand and comply with its requirements and good pharmacy practice. Inspections are fundamental to providing public protection.
Geoff McCurdy, a VPA inspector since 2013, recently announced his retirement. Geoff is well known to many pharmacists, particularly in hospital pharmacy as the focus of his work with the VPA was on hospital pharmacy departments. In addition to conducting inspections, Geoff used his experience and expertise to assess applications for new and altered pharmacy departments and conduct a risk-based review of sterile compounding facilities in Victorian hospitals.
Geoff had plans to retire before the COVID-19 pandemic, then kindly offered to continue to support the VPA during the course of the pandemic and while the Authority recruited a new hospital pharmacy inspector. We are very grateful for Geoff’s contributions to the work of the Authority and for postponing his initial retirement plans.
We will miss Geoff very much and wish him well in his retirement.
Welcome Scott Savage
The Authority welcomes Mr Scott Savage to its staff as an inspector. Scott is a registered pharmacist with extensive experience in both hospital and community pharmacy, including as a director of pharmacy in hospital pharmacy departments. His primary focus will be pharmacy department inspections. He commenced his employment with the Authority in February 2022.
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.
Compounding worksheets
Pharmacists are expected to document and retain records of the preparation of compounded products in both simple and complex compounding as per the Pharmacy Board of Australia Guidelines on compounding of medicines. Information published in the section Extemporaneous dispensing in the current edition of the Australian Pharmaceutical Formulary and Handbook offers guidance on the key requirements for compounding worksheets. Appropriate documentation forms an integral part of record keeping, as well as supporting the quality assurance of compounding activities and enabling the timely recall and quarantine of compounded preparations including raw materials if required.
Weighing equipment
Pharmacies are required to be equipped with working Class 1 or Class 2 approved scales, irrespective of the range of compounding services provided by the pharmacy. An ‘approved’ scale means that the make and model of the scale has been approved by the National Measurement Institute (NMI). Servicing and calibration of the dispensing scales should be carried out at regular intervals as recommended by the manufacturer or scale servicing company.
Please refer to the VPA Guidelines for additional information regarding dispensing equipment.
Facilitating a final check of the dispensed medicine
A final check of the dispensed medicine at the time of supply is an important part of the dispensing process to ensure that the correct drug, strength, formulation and dose is supplied to the correct patient. To facilitate this, a hard copy of the prescription may be kept with the dispensed medicine until supply is made. If a pharmacy chooses not to print a hard copy of electronic prescriptions, it should implement a separate procedure to allow a final check of the dispensed medicine against the electronic prescription at the time of supply. Refer to the Pharmacy Board of Australia Guidelines for dispensing of medicines for information regarding the dispensing process.
For information
COVID-19 Antiviral Medicines – Authorisation – Residential Aged Care Facilities
As you may already be aware, Public Health Emergency Order #17 came into force on 9 February 2022. The gazette notice can be found here.
PHEO #17 (Covid-19 Medicines - Authorisation – Residential Aged Care Facilities) is intended to facilitate the supply of antiviral medicines registered for the treatment of COVID-19 and supplied by the Australian Government Department of Health from the National Medical Stockpile to residential aged care facilities in Victoria.
The prescribing, administration, storage, record keeping and disposal of the medicines must be in accordance with the requirements of the Drugs, Poisons and Controlled Substances Act 1981, the Regulations and any other applicable Victorian or Commonwealth legislation, and subject to the residential aged care facilities complying with the requirements of manufacturers’ directions.
Guidance documents relating to administration, prescribing, storage and record keeping of scheduled medicines can be found on the Medicines and Poisons Regulation webpage.
For queries about the Order and medicines and poisons regulatory requirements in Victoria please contact dpcs@health.vic.gov.au.
Risk Assessments for compounding
A recent practice alert from Pharmaceutical Defence Limited (PDL) regarding the compounding of clonidine preparations highlighted the importance of conducting risk assessments for each compounded preparation. It is recommended that where pharmacists have established that they are not equipped with the skills, equipment nor evidence of quality assurance processes to prepare the medication, they should refer the compounding to a pharmacy that employs appropriate protocols and skilled staff. Additional information is available in the Risk assessment process for the preparation of extemporaneous preparations outlined in the section Extemporaneous dispensing in the current edition of the Australian Pharmaceutical Formulary and Handbook.
The Pharmacy Council of NSW has also recently published useful information here.
Resources
Supporting key learnings from recent inspections and areas of high risk, licensees and pharmacists may wish to refer to the following resources alongside the VPA Guidelines. Resources are not limited to the list below and pharmacists are encouraged to review other relevant references as required.
- Pharmacy Board of Australia Guidelines on compounding medicines here.
- Pharmacy Board of Australia Guidelines for proprietor pharmacists 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.
- Pharmacy Board of Australia Guidelines for dispensing of medicines here.
- Pharmaceutical Society of Australia’s Professional Practice Standards 2017 here.
- Pharmaceutical Society of Australia's Guidelines for Pharmacists Providing Dose Administration Aid Services here.
- DPCS Regulations 2017 with reference to requirements for recording, storage and reconciliation of Schedule 8 poisons here.
- Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs here.
- Medicines and Poisons Regulation: Managing Schedule 8 poisons here.
- Medicines and Poisons Regulation: Dispensing medicines here.
- National Vaccine Storage Guidelines 'Strive for 5' here.
Members of the Victorian Pharmacy Authority
Mr D McConville, Chair (Pharmacist member)
Ms E Kennedy (Lawyer member)
Ms C Fersterer (Pharmacist member)
Mr B Moar (Pharmacist member)
Ms M Ritchie (Community member)
Mr D Sanghvi (Pharmacist member)
Authority Staff
Registrar: Mr A Bawden
Senior Pharmacist: Mr D Thirlwall
Pharmacist: Mrs C Greco (Program Officer - Licensing and Registration)
Pharmacist: Dr J Snell (Governance and Risk Officer)
Pharmacist: Ms J Webster (Authorised Officer)
Pharmacist: Ms T To (Authorised Officer)
Pharmacist: Ms K La (Authorised Officer)
Pharmacist: Mr S Savage (Authorised Officer)
Chief Finance Officer: Mrs K Nadanakumar
Administration Officer: Mrs H Newett
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
