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No images? Click here  Victorian Pharmacy Authority Circular No. 36 - December 2024 In this Circular
Chair's Message Welcome to the VPA’s December circular. A highlight of this year has been the improved inspection program with an enhanced focus on the VPA Standards and other high-risk areas. The updated premises self-audit form provides a tool for licensees to monitor their own compliance, better prepare for inspections and facilitate more efficient inspections. There are also clear business benefits arising from improved compliance. Proprietors are reminded to be aware of their responsibilities and obligations, ensuring compliance with legislation and the VPA Standards in registered premises, consistent with the Pharmacy Board of Australia's Guidelines for proprietor pharmacists. Licensees are expected to show proactive leadership, management and good governance in their pharmacies and to ensure systems are in place to ensure ongoing compliance in their absence. In this circular, we include information on the VPA’s public register and a reminder about the requirement to notify the VPA whenever there is a change to any pharmacy business commercial arrangements. We include an update on recent Panel hearing outcomes and a case study highlighting how a comprehensive response to an inspection may circumvent further action by the Authority. 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 Applications are now open for The Hon. Mary-Anne Thomas MP, Minister for Health is pleased to invite applications for appointments to the following three positions on the Victorian Pharmacy Authority (Authority): 2 x Pharmacist member (for a registered pharmacist only) 1 x Lawyer member 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 2025. For further information or to make an application, visit the Join a Public Board website at <www.boards.vic.gov.au>. Please review the Guidelines and the Victorian Pharmacy member position description located on Join a Public Board website prior to applying for this role. Applications close at midnight on 2 February 2025. For enquiries about the position please contact Brendan Gorrie at the Department of Health on (03) 9500 4116. 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. VPA Public register - important messages The VPA public register includes details of all Victorian licensees and registered premises including the name of each licensee, the registration status of the premises and any conditions on a licence or registration. The register may be searched by premises (business name or postcode) or owner. Stakeholders including wholesalers and suppliers should note that certificates should never be used to confirm licence or premises registration status. The VPA public register is the only way to verify current licence or registration status. Employee pharmacists including locums should review the VPA public register prior to commencing employment or engaging in any pharmacy services to confirm the registration status of the pharmacy and make themselves aware of any conditions applicable to the pharmacy premises or the licensees. The VPA public register can be accessed on the VPA website here. Did you know? Licensees are reminded 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:
The VP31 Notification of a change to commercial arrangements for a pharmacy business form is available to download on the VPA website for this purpose here. Feedback on VPA inspections We encourage licensees to provide feedback on VPA inspections. An improved process to proactively obtain feedback from pharmacists on VPA inspections was developed for the 2024-25 financial year. On a quarterly basis, 20 pharmacy premises will be randomly selected to provide feedback via a short, focused questionnaire. The process includes the development of metrics to determine the effectiveness of the inspection program to address public harms. The VPA welcomes feedback and routinely provides a link in covering letters to inspection reports for licensees to provide feedback on inspection processes. Feedback received may be used to review inspection processes and for internal training purposes. From the inspectors In early 2025, VPA inspectors will continue to undertake targeted inspections focusing on indirect supply arrangements. Licensees of pharmacies supplying medicines indirectly to patients, including internet or mail-order dispensing, should ensure they comply with all relevant legislation, guidelines and good pharmacy practice. This includes pharmacies supplying medicinal cannabis. Licensees should ensure that arrangements involving indirect supply are adequately covered by policies and procedures meeting the requirements of standards 1.4.1-1.4.3 of the VPA Standards. Case study This case illustrates a regulatory option available to the Authority when dealing with a pharmacy not complying with basic requirements of the Act and the VPA Standards. An inspection identified an unacceptable level of clutter, uncleanliness and lack of hygiene posing a significant risk to public health. There was a range of failures of good pharmacy practice. The Authority initially gave the licensee notice of its intention to revoke the premises registration unless the licensee remedied the failures within a specified period. During the inspection, the inspectors obtained evidence of non-compliance with requirements relating to the VPA Standards and the Pharmacy Regulation Act 2010 as follows:
There was water damage and leaking from walls and ceilings, with buckets on the flooring/shelving to catch leaks, including areas where medicines were stored. Damaged stock was also observed.
The pharmacy was cluttered and disorganised in all areas, including dispensing and compounding benches, the dispensary floor and vaccination room. Various items were observed throughout the dispensary which was also being used to store staff personal belongings.
There was not sufficient storage space for the S8 stock on hand, despite the pharmacy having multiple S8 safes. Each S8 safe was full and most of the stock was stored in a manner that required removal of other S8 poisons in order to access specific products. S8 poisons received by wholesale were stored on open shelving until the pharmacists had the time to place them in the S8 safes. Dispensed S8 poisons assembled for postal dispatch were stored on open shelving. Returned and unwanted S4 poisons were stored in a rear storage area outside the dispensary and accessible to all staff.
There was a discrepancy between the S8 Register balance and actual stock on hand for at least half of the stock lines checked. There were almost 200 outstanding S8 transactions that had not been recorded into the S8 Register. A S8 safe dedicated to returned or unwanted S8 poisons was relatively full and would have limited capacity to store additional S8 returns.
The methadone dosing pump was dirty and stained. Staff were unable to confirm whether cleaning of equipment was routinely undertaken and could not locate cleaning and maintenance logs for the DAA packing robot. The Authority was appalled by the lack of cleanliness and hygiene, the associated level of clutter and failures of good pharmacy practice, which it considered to pose a significant risk to public health and safety. Noting that the state of the premises and the licensee’s failure to carry on the pharmacy business in accordance with the Act and good pharmacy practice provided grounds to revoke the registration of premises, the Authority gave the licensee notice of its intention to revoke the premises registration unless, at the end of 28 days, satisfactory arrangements were made to address the specified failures. After considering the licensee’s comprehensive written response and the report of a subsequent inspection noting substantial improvements, the Authority resolved not to proceed with the revocation of the registration and ordered a further reinspection of the premises to be undertaken after 6 months.
Lessons for licensees:
The benefits of self-auditing The VPA strongly encourages licensees to utilise the self-audit form to help prepare for inspections. The self-audit form is designed to assist licensees and pharmacists to monitor their compliance with key requirements of the Act, VPA Standards, VPA Guidelines and good pharmacy practice. Improvements were recently made to the pharmacy self-audit form to highlight high-risk areas routinely covered during VPA inspections, including frequently observed non-compliances. It is recommended that newly established services or high-risk areas are audited at least twice a year. As systems become stable and well documented, the audit frequency can reduce to at least annually. There are separate self-audit forms for specific pharmacy services. The VPA self-audit form also provides a useful tool for licensees to prepare for inspections. The current version of the self-audit form dated 30 June 2024 is available here. Recent panel hearings The VPA conducted 27 panel hearings during the 2023-24 financial year into allegations that licensees failed to meet their responsibilities to comply with the Pharmacy Regulation Act 2010 (the Act) and VPA Standards. Panel hearings are convened for serious breaches of the Act and the VPA Standards. Determinations of the panels were as follows:
Thirteen further panel hearings were conducted between July and December 2024. Eight hearings resulted in reprimands; five hearings resulted in the licensees being cautioned. Nine of the hearings also resulted in a condition being imposed requiring a reinspection at the licensee’s cost. Examples of common non-compliances which featured in panel hearings include:
For information Registered pharmacists need to renew their AHPRA registration annually. Pharmacists who do not apply to renew their registration with AHPRA by 31 December 2024 (end of late period) will have lapsed registration and will not be able to practise. A pharmacist licensee whose registration as a pharmacist lapses is no longer eligible to own or have a proprietary interest in a pharmacy business and their 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 who own or have a proprietary interest in a Victorian pharmacy are reminded to check their registration status and renew their registration if they have not already done so. Pharmacists can check their registration details and expiry date on the AHPRA Register of practitioners. Sterile compounding exemptions in hospital pharmacy departments – clarification Circular No.34 included a reminder about compounding exemptions under therapeutic goods legislation:
The VPA notes that for therapeutic goods compounded in hospital pharmacy departments, this exemption extends to include medicines:
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
S8 management
Vaccination
Other resources
Members of the Victorian Pharmacy Authority Mr David McConville, Chair (Pharmacist member) VPA Staff Registrar: Mr Aaron Bawden The VPA Circular is a document issued by the Victoria Pharmacy Authority (VPA) in Australia. It provides important information and updates to pharmacists and pharmacy stakeholders. You can review this circular and previous circulars on the VPA website here.   |
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