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Circular No. 29 - 28 July 2022

Circular No. 29 - 28 July 2022

In this Circular

Chair’s message

Special focus

  • VPA Standards – forthcoming webinars
  • Communication survey

Welcome Regina Cowie

Applications: Notification of completion

Quarterly performance report

From the inspectors

  • Pharmacotherapy
  • Dispensary activities and access
  • COVID-19 vaccine preparation and labelling

Recent panel hearings

For information

  • Fraudulent prescription alerts
  • Revocation of pharmacist’s approval following criminal conviction
  • Pharmacists’ Support Service

Resources

Chair's message

Welcome to the VPA’s July circular.

We are mailing hard copies of the Victorian Pharmacy Authority Standards (VPA Standards) to all registered premises which should arrive in the coming week. Please make the VPA Standards available to all pharmacy staff.

The VPA is conducting a survey aimed at improving communication with stakeholders including licensees and pharmacists and your valued feedback would be appreciated.

This Circular provides guidance from inspectors on areas including pharmacotherapy, maintaining a dedicated and private dispensary and COVID-19 vaccination dose preparation and labelling.

There were five panel hearings in the last quarter. One hearing highlights the importance of regularly monitoring the pharmacy’s operation to assess whether premises are still adequate in terms of size and suitability to meet increased service demands and workload.

I would like to take this opportunity to thank outgoing pharmacist member Cassie Fersterer for her contributions to the work of the VPA over the last 6 years.

Lastly, I would like to welcome new VPA pharmacist member Regina Cowie.

 

David McConville
Chair

 

Special focus

VPA Standards – forthcoming webinars

The VPA Standards became effective on 12 May 2022. Licensees are responsible for meeting the VPA Standards which are now mandatory requirements for Victorian pharmacies, pharmacy businesses and pharmacy departments.

Hard copies of the VPA Standards are being mailed to all registered premises. Pharmacists are encouraged to keep the copy in a prominent area of the dispensary for easy access and reference and to bookmark the electronic version on your dispensing computers.

The VPA will be holding webinars to support compliance with the VPA Standards and more details will be provided in a forthcoming dedicated email.

Due to the constraints of an online webinar, we invite you to submit your questions about the VPA Standards by emailing enquiries@pharmacy.vic.gov.au with your query. We will endeavour to address your questions during the webinar.

Communication survey

The VPA is evaluating how effectively it communicates with stakeholders via its circulars, communiqués, and website to identify opportunities for improvement.

The VPA communicates with licensees, registered premises and other stakeholders by issuing

  • regular quarterly circulars about its activities; and
  • ad hoc communiqués about important matters as they arise

Circulars and communiqués are distributed by email and also published on the VPA website. Stakeholders can request to receive these news items by sending a request to the VPA at enquiries@pharmacy.vic.gov.au.

The VPA appreciates your time in completing this short survey .

Welcome Regina Cowie

Regina Cowie was appointed by the Governor in Council as a pharmacist member of the VPA for a three-year term from 30 June 2022 until 30 June 2025.

Regina has a Bachelor of Sports Science (Exercise Physiologist) and is a qualified accredited pharmacist with over 20 years’ experience in community (metro, rural and remote), industry and corporate pharmacy. Regina developed the first intern training program for the Northern Territory and Pharmaceutical Society of Australia. Regina has a passion for innovation, health care service delivery and the use of technology to provide equality of health care. Regina is heavily involved in the electronic prescription roll out for community and hospitals, electronic medication charts and increasing the uptake of the active script list. Regina is currently on the Pharmaceutical Society of Australia Academic Advisory Board and Alcon Advisory Board. Regina is the Partnerships Manager across eHealth for the Fred IT Group.

Applications

Notification of completion

Notifications of completion of alterations to existing registered pharmacy premises should only be submitted to VPA when works have been completed.

There have been instances where inspectors have found this not to be the case (for example the incomplete construction of a new compounding laboratory) even though a notification of completion was submitted to the VPA.

Licensees who are assisted by a banner group head office with the submission of this form should make sure that head office does so only when work has been completed.

Licensees should contact the VPA for an extension if they are unable to complete the construction of the agreed premises within the specified timeframe.

Licensees are reminded that notifications of completion of new/altered premises require a statutory declaration in relation to the truthfulness and accuracy of the information provided.

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 January 2022 to 31 March 2022 is available on the VPA website.

Recent panel hearings

The Authority held five Panel Hearings between April and June 2022 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises.

A summary of a selection of hearings follows:

Case 1

The pharmacy had experienced significant growth in prescription numbers and no longer complied with a range of requirements.

There was not sufficient space in the drug safes to store S8 poisons. Multiple S8 poisons were stored in large boxes near the drug safe while some drug safes were too full to close at the time of inspection. Not all drug safes were secured in accordance with drugs and poisons legislation (insufficient number of bolts) and the drug register did not reflect the true and accurate balance of S8 medicines as there were multiple unentered S8 invoices.

The pharmacy had outgrown its dispensary and as such additional dispensary activities were being undertaken upstairs in a room that was not approved by the VPA. There was also non-compliance with requirements relating to security and privacy.

The licensee was reprimanded.

Learnings

VPA approval must be obtained prior to making significant alterations to registered premises. This is so that the VPA can ensure that the premises remain suitable and do not present a risk to public safety. The VP21 application form is available on the VPA website.

VPA Standard 2.4.2(f) now requires the dispensary to be fitted with a dedicated storage facility for S8 and S9 poisons which complies with legislation, provides adequate storage for poisons on hand at all times and facilitates their accurate selection. A larger drug safe or an additional drug safe(s) must be obtained if the existing safe does not provide enough storage. Drug safes must remain locked and secured at all times, except when it is necessary to open them to carry out an essential operation in connection with the poisons stored in them.

Pharmacists are required to make true and accurate records of all transactions of S8 poisons in the drug register, where possible immediately at the time of supply or receipt but no later than the same day of the transaction. This allows for immediate detection of any discrepancy for further investigation.

VPA Standard 1.3.3 highlights a licensee’s responsibility for ensuring that records for S8 and S9 poisons are maintained in accordance with legislation. Licensees can do this by exercising oversight over the pharmacy’s operation and ensuring that there are policies and procedures (VPA Standard 1.4) in place in relation to S8 management that are available to all staff and that they are being followed.

Pharmacists are encouraged to access the quick reference guide developed by the VPA to support pharmacists to understand and meet their obligations when managing Schedule 8 poisons: Managing Schedule 8 poisons – a reference guide for pharmacists.

Case 2

The pharmacy had shown ongoing non-compliance over multiple inspections in the following areas:

  • Staff were not able to access current reference texts.
  • Inadequate confidential waste management (confidential waste was combined with general waste).
  • Discrepancies between the drug register and actual S8 poisons on hand. It was observed at this inspection that broken packs were not accounted for in the drug register.
  • S8 poisons held for destruction were not recorded in the drug register for destruction.
  • Failure to maintain photographs of all pharmacotherapy clients.
  • Unsatisfactory barcode scanning rates.
  • Inadequate cold chain management of the drug refrigerator.
  • Scales for simple compounding had not been serviced.

Sublingual buprenorphine tablets were removed from their blister packaging and stored in a vial rather than kept in the original packaging until the time of administration. This practice increases the risk of moisture absorption which can compromise the integrity of the medicine. There were other areas of non-compliance in relation to vaccination and S4 storage requirements.

The licensee was reprimanded and the panel imposed a condition requiring the licensee to submit to a further inspection of the pharmacy at their cost.

Learnings

The VPA inspects pharmacies to ensure that they comply with legislation and good pharmacy practice. Licensees are expected to take measures to rectify areas of non-compliance and to take appropriate steps to prevent re-occurrence.

S8 poisons held for destruction must be entered into the drug register for destruction when they are received or identified and entered out on the day of destruction. This ensures that S8 poisons are accounted for at the time of receipt and destruction. They should be destroyed as soon as possible to reduce the risk of misappropriation and free up storage space in the drug safe.

Case 3

The licensee contravened the Act by permitting a company to carry on a business in the registered premises that was not permitted by the licence or approved by the Authority, in breach of section 24 of the Act.

The director of the company held 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.

Further, the licensee failed to comply with the condition of the licence to inform the Authority of any changes to the commercial arrangements pursuant to which the pharmacy business is conducted prior to those changes taking effect.

The licensee was reprimanded.

In this case, the licence could have been revoked or the company prosecuted for carrying on the pharmacy business without a licence.

Learnings

Pharmacists holding a licence as a natural person must apply for a new licence when planning to switch to a corporate structure. Pharmacists should take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

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.

Pharmacotherapy

Inspectors remind pharmacists that:

  • Take-away doses should be labelled in accordance with the Policy for maintenance pharmacotherapy for opioid dependence issued by the Department of Health. Examples of take-away labels are available in the policy for reference.
  • Each pharmacotherapy client must have a current photograph readily available at the time of administration.
  • Transactions of methadone and buprenorphine must be recorded daily in the drug register. Drugs, Poisons and Controlled Substances Regulations 2017 requires records of all transactions in respect of methadone and buprenorphine to be made at least daily if the transaction is for the purpose of opioid replacement therapy.
  • Benches used for the preparation of pharmacotherapy doses should be clean and free from clutter. Clutter may cause distractions and dosing errors.
  • Disposable syringes used to measure doses should be disposed of regularly and replaced with new ones to reduce the risk of errors resulting from fading measurement markings and for hygienic reasons.

Pharmacists and pharmacy staff new to this service or those who would benefit from a refresher are encouraged to complete the free Victorian Opioid Pharmacotherapy Program provided by the Pharmaceutical Society of Australia. This training program is designed to enable pharmacists and pharmacy staff to deliver a safe and patient-centered pharmacotherapy service.

Dispensary activities and access

VPA standard 2.4.1 requires the dispensary to be a private area, dedicated to tasks associated with the dispensing, supply and compounding of medicines and secure storage of medicines and patient records.

Inspectors remind pharmacists that:

  • The dispensary should not be used to store retail products.
  • The dispensary should not be used to undertake non-dispensary related activities e.g. preparing price tags and unpacking retail stock.
  • Non-dispensary personnel should not be accessing the dispensary to make retail-related phone calls or engage in social activities.

Access to the dispensary should only occur under the direct supervision of a registered pharmacist and by dispensary qualified or trained personnel undertaking a dispensary related activity. The dispensary must be maintained as a private and dedicated area so that:

  • distraction to pharmacists and dispensing staff is minimised;
  • patient records are kept private; and
  • the security of medicines is assured.

COVID-19 vaccine preparation and labelling

According to the Victorian COVID-19 Vaccination Guidelines and/or Commonwealth COVID-19 Vaccination Training Program (training program):

  • Each prepared syringes of COVID-19 vaccines should be appropriately labelled with the date and time doses were drawn; the name of the person who prepared the doses; vaccine name; vial batch number; expiry time of drawn doses and vial identifier (if available). Labelling reduces the risk of incorrect vaccine selection and enables a final check prior to administration to ensure the right vaccine is given to the right patient.
  • A multi-dose vial should never be stored in the fridge with a drawing up needle left in its bung. This is in accordance with infection control principles aimed at reducing the risk of cross contamination. The drawing up needle can only remain in the vial while immediately drawing up doses. This is consistent with the Guidance on the use of multi-dose vials for COVID-19 vaccination from the Australian Technical Advisor Group on Immuisation (ATAGI).

Further, the vaccine preparation area should be hygienic and free of clutter. VPA Standards 2.1.2 requires the registered premises to be maintained in an organised, unclutter state white VPA Guidelines 4.3.13 requires that the preparation area has a cleaning and disinfection schedule in place.

For information

Fraudulent prescription alerts

The Medicines and Poisons Regulation (MPR) branch of the Department of Health includes important information and guidance documents for pharmacists on its website.

The Fraudulent prescription alerts webpage has been updated to provide:

  • guidance for pharmacists regarding what to do after receiving a fraudulent prescription;
  • information on current and recent fraudulent prescription alerts;
  • examples of other prescription scams; and
  • a list of advice to clarify common misunderstandings that led to fraudulent prescriptions being dispensed.

The Stolen and forged prescriptions webpage provides details of practitioners whose names have been used on fraudulent prescriptions or stolen prescriptions that have been reported to MPR.

Pharmacists are encouraged to review the contents, visit the website regularly for updates and to bookmark the website for ease of reference.

Revocation of pharmacist’s approval following criminal conviction

A NSW pharmacist, who was found guilty of defrauding taxpayers more than $350,000 through falsely claiming benefits under the Pharmaceutical Benefits Scheme (PBS), has had their approval revoked by the Department of Health.

The revocation follows the pharmacist’s conviction by the New South Wales District Court on 12 March 2021 with an offence of engaging in a course of conduct with the intention of dishonestly obtaining a gain from the Commonwealth, contrary to section 135.1(1) of the Criminal Code Act 1995.

The revocation decision, which came into effect 8 April 2022, means the pharmacist ceased to be an approved pharmacist from that date and is no longer able to supply PBS medicines or receive payment from the Commonwealth for the supply of PBS medicines.

Details of the Department of Health and Aged Care’s decision can be found here.

Pharmacists’ Support Service

Pharmacists’ Support Service (PSS) is a free service run by pharmacists for pharmacists that is available 365 days a year from 8am to 11pm AEST on 1300 244 910.

The type of issues leading pharmacists to seek support from PSS include (but are not limited to) crime related trauma, workplace and workload concerns, employment matters, substance abuse, mental health issues, suicide, ill-health, difficulties arising from professional and financial pressures, practice matters and ethical issues. A common feature is stress.

There are also useful resources available on the PSS website that pharmacists may find helpful.

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 Standards and 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 R Cowie   (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

In this Circular

Chair’s message

Special focus

  • VPA Standards – forthcoming webinars
  • Communication survey

Welcome Regina Cowie

Applications: Notification of completion

Quarterly performance report

From the inspectors

  • Pharmacotherapy
  • Dispensary activities and access
  • COVID-19 vaccine preparation and labelling

Recent panel hearings

For information

  • Fraudulent prescription alerts
  • Revocation of pharmacist’s approval following criminal conviction
  • Pharmacists’ Support Service

Resources

Chair's message

Welcome to the VPA’s July circular.

We are mailing hard copies of the Victorian Pharmacy Authority Standards (VPA Standards) to all registered premises which should arrive in the coming week. Please make the VPA Standards available to all pharmacy staff.

The VPA is conducting a survey aimed at improving communication with stakeholders including licensees and pharmacists and your valued feedback would be appreciated.

This Circular provides guidance from inspectors on areas including pharmacotherapy, maintaining a dedicated and private dispensary and COVID-19 vaccination dose preparation and labelling.

There were five panel hearings in the last quarter. One hearing highlights the importance of regularly monitoring the pharmacy’s operation to assess whether premises are still adequate in terms of size and suitability to meet increased service demands and workload.

I would like to take this opportunity to thank outgoing pharmacist member Cassie Fersterer for her contributions to the work of the VPA over the last 6 years.

Lastly, I would like to welcome new VPA pharmacist member Regina Cowie.

 

David McConville
Chair

 

Special focus

VPA Standards – forthcoming webinars

The VPA Standards became effective on 12 May 2022. Licensees are responsible for meeting the VPA Standards which are now mandatory requirements for Victorian pharmacies, pharmacy businesses and pharmacy departments.

Hard copies of the VPA Standards are being mailed to all registered premises. Pharmacists are encouraged to keep the copy in a prominent area of the dispensary for easy access and reference and to bookmark the electronic version on your dispensing computers.

The VPA will be holding webinars to support compliance with the VPA Standards and more details will be provided in a forthcoming dedicated email.

Due to the constraints of an online webinar, we invite you to submit your questions about the VPA Standards by emailing enquiries@pharmacy.vic.gov.au with your query. We will endeavour to address your questions during the webinar.

Communication survey

The VPA is evaluating how effectively it communicates with stakeholders via its circulars, communiqués, and website to identify opportunities for improvement.

The VPA communicates with licensees, registered premises and other stakeholders by issuing

  • regular quarterly circulars about its activities; and
  • ad hoc communiqués about important matters as they arise

Circulars and communiqués are distributed by email and also published on the VPA website. Stakeholders can request to receive these news items by sending a request to the VPA at enquiries@pharmacy.vic.gov.au.

The VPA appreciates your time in completing this short survey .

Welcome Regina Cowie

Regina Cowie was appointed by the Governor in Council as a pharmacist member of the VPA for a three-year term from 30 June 2022 until 30 June 2025.

Regina has a Bachelor of Sports Science (Exercise Physiologist) and is a qualified accredited pharmacist with over 20 years’ experience in community (metro, rural and remote), industry and corporate pharmacy. Regina developed the first intern training program for the Northern Territory and Pharmaceutical Society of Australia. Regina has a passion for innovation, health care service delivery and the use of technology to provide equality of health care. Regina is heavily involved in the electronic prescription roll out for community and hospitals, electronic medication charts and increasing the uptake of the active script list. Regina is currently on the Pharmaceutical Society of Australia Academic Advisory Board and Alcon Advisory Board. Regina is the Partnerships Manager across eHealth for the Fred IT Group.

Applications

Notification of completion

Notifications of completion of alterations to existing registered pharmacy premises should only be submitted to VPA when works have been completed.

There have been instances where inspectors have found this not to be the case (for example the incomplete construction of a new compounding laboratory) even though a notification of completion was submitted to the VPA.

Licensees who are assisted by a banner group head office with the submission of this form should make sure that head office does so only when work has been completed.

Licensees should contact the VPA for an extension if they are unable to complete the construction of the agreed premises within the specified timeframe.

Licensees are reminded that notifications of completion of new/altered premises require a statutory declaration in relation to the truthfulness and accuracy of the information provided.

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 January 2022 to 31 March 2022 is available on the VPA website.

Recent panel hearings

The Authority held five Panel Hearings between April and June 2022 into allegations that licensees had failed to meet their responsibilities to comply with the Act and/or good pharmacy practice at registered premises.

A summary of a selection of hearings follows:

Case 1

The pharmacy had experienced significant growth in prescription numbers and no longer complied with a range of requirements.

There was not sufficient space in the drug safes to store S8 poisons. Multiple S8 poisons were stored in large boxes near the drug safe while some drug safes were too full to close at the time of inspection. Not all drug safes were secured in accordance with drugs and poisons legislation (insufficient number of bolts) and the drug register did not reflect the true and accurate balance of S8 medicines as there were multiple unentered S8 invoices.

The pharmacy had outgrown its dispensary and as such additional dispensary activities were being undertaken upstairs in a room that was not approved by the VPA. There was also non-compliance with requirements relating to security and privacy.

The licensee was reprimanded.

Learnings

VPA approval must be obtained prior to making significant alterations to registered premises. This is so that the VPA can ensure that the premises remain suitable and do not present a risk to public safety. The VP21 application form is available on the VPA website.

VPA Standard 2.4.2(f) now requires the dispensary to be fitted with a dedicated storage facility for S8 and S9 poisons which complies with legislation, provides adequate storage for poisons on hand at all times and facilitates their accurate selection. A larger drug safe or an additional drug safe(s) must be obtained if the existing safe does not provide enough storage. Drug safes must remain locked and secured at all times, except when it is necessary to open them to carry out an essential operation in connection with the poisons stored in them.

Pharmacists are required to make true and accurate records of all transactions of S8 poisons in the drug register, where possible immediately at the time of supply or receipt but no later than the same day of the transaction. This allows for immediate detection of any discrepancy for further investigation.

VPA Standard 1.3.3 highlights a licensee’s responsibility for ensuring that records for S8 and S9 poisons are maintained in accordance with legislation. Licensees can do this by exercising oversight over the pharmacy’s operation and ensuring that there are policies and procedures (VPA Standard 1.4) in place in relation to S8 management that are available to all staff and that they are being followed.

Pharmacists are encouraged to access the quick reference guide developed by the VPA to support pharmacists to understand and meet their obligations when managing Schedule 8 poisons: Managing Schedule 8 poisons – a reference guide for pharmacists.

Case 2

The pharmacy had shown ongoing non-compliance over multiple inspections in the following areas:

  • Staff were not able to access current reference texts.
  • Inadequate confidential waste management (confidential waste was combined with general waste).
  • Discrepancies between the drug register and actual S8 poisons on hand. It was observed at this inspection that broken packs were not accounted for in the drug register.
  • S8 poisons held for destruction were not recorded in the drug register for destruction.
  • Failure to maintain photographs of all pharmacotherapy clients.
  • Unsatisfactory barcode scanning rates.
  • Inadequate cold chain management of the drug refrigerator.
  • Scales for simple compounding had not been serviced.

Sublingual buprenorphine tablets were removed from their blister packaging and stored in a vial rather than kept in the original packaging until the time of administration. This practice increases the risk of moisture absorption which can compromise the integrity of the medicine. There were other areas of non-compliance in relation to vaccination and S4 storage requirements.

The licensee was reprimanded and the panel imposed a condition requiring the licensee to submit to a further inspection of the pharmacy at their cost.

Learnings

The VPA inspects pharmacies to ensure that they comply with legislation and good pharmacy practice. Licensees are expected to take measures to rectify areas of non-compliance and to take appropriate steps to prevent re-occurrence.

S8 poisons held for destruction must be entered into the drug register for destruction when they are received or identified and entered out on the day of destruction. This ensures that S8 poisons are accounted for at the time of receipt and destruction. They should be destroyed as soon as possible to reduce the risk of misappropriation and free up storage space in the drug safe.

Case 3

The licensee contravened the Act by permitting a company to carry on a business in the registered premises that was not permitted by the licence or approved by the Authority, in breach of section 24 of the Act.

The director of the company held 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.

Further, the licensee failed to comply with the condition of the licence to inform the Authority of any changes to the commercial arrangements pursuant to which the pharmacy business is conducted prior to those changes taking effect.

The licensee was reprimanded.

In this case, the licence could have been revoked or the company prosecuted for carrying on the pharmacy business without a licence.

Learnings

Pharmacists holding a licence as a natural person must apply for a new licence when planning to switch to a corporate structure. Pharmacists should take the necessary steps to satisfy themselves that proposed ownership and commercial arrangements comply with the Act and not rely solely on their advisers.

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.

Pharmacotherapy

Inspectors remind pharmacists that:

  • Take-away doses should be labelled in accordance with the Policy for maintenance pharmacotherapy for opioid dependence issued by the Department of Health. Examples of take-away labels are available in the policy for reference.
  • Each pharmacotherapy client must have a current photograph readily available at the time of administration.
  • Transactions of methadone and buprenorphine must be recorded daily in the drug register. Drugs, Poisons and Controlled Substances Regulations 2017 requires records of all transactions in respect of methadone and buprenorphine to be made at least daily if the transaction is for the purpose of opioid replacement therapy.
  • Benches used for the preparation of pharmacotherapy doses should be clean and free from clutter. Clutter may cause distractions and dosing errors.
  • Disposable syringes used to measure doses should be disposed of regularly and replaced with new ones to reduce the risk of errors resulting from fading measurement markings and for hygienic reasons.

Pharmacists and pharmacy staff new to this service or those who would benefit from a refresher are encouraged to complete the free Victorian Opioid Pharmacotherapy Program provided by the Pharmaceutical Society of Australia. This training program is designed to enable pharmacists and pharmacy staff to deliver a safe and patient-centered pharmacotherapy service.

Dispensary activities and access

VPA standard 2.4.1 requires the dispensary to be a private area, dedicated to tasks associated with the dispensing, supply and compounding of medicines and secure storage of medicines and patient records.

Inspectors remind pharmacists that:

  • The dispensary should not be used to store retail products.
  • The dispensary should not be used to undertake non-dispensary related activities e.g. preparing price tags and unpacking retail stock.
  • Non-dispensary personnel should not be accessing the dispensary to make retail-related phone calls or engage in social activities.

Access to the dispensary should only occur under the direct supervision of a registered pharmacist and by dispensary qualified or trained personnel undertaking a dispensary related activity. The dispensary must be maintained as a private and dedicated area so that:

  • distraction to pharmacists and dispensing staff is minimised;
  • patient records are kept private; and
  • the security of medicines is assured.

COVID-19 vaccine preparation and labelling

According to the Victorian COVID-19 Vaccination Guidelines and/or Commonwealth COVID-19 Vaccination Training Program (training program):

  • Each prepared syringes of COVID-19 vaccines should be appropriately labelled with the date and time doses were drawn; the name of the person who prepared the doses; vaccine name; vial batch number; expiry time of drawn doses and vial identifier (if available). Labelling reduces the risk of incorrect vaccine selection and enables a final check prior to administration to ensure the right vaccine is given to the right patient.
  • A multi-dose vial should never be stored in the fridge with a drawing up needle left in its bung. This is in accordance with infection control principles aimed at reducing the risk of cross contamination. The drawing up needle can only remain in the vial while immediately drawing up doses. This is consistent with the Guidance on the use of multi-dose vials for COVID-19 vaccination from the Australian Technical Advisor Group on Immuisation (ATAGI).

Further, the vaccine preparation area should be hygienic and free of clutter. VPA Standards 2.1.2 requires the registered premises to be maintained in an organised, unclutter state white VPA Guidelines 4.3.13 requires that the preparation area has a cleaning and disinfection schedule in place.

For information

Fraudulent prescription alerts

The Medicines and Poisons Regulation (MPR) branch of the Department of Health includes important information and guidance documents for pharmacists on its website.

The Fraudulent prescription alerts webpage has been updated to provide:

  • guidance for pharmacists regarding what to do after receiving a fraudulent prescription;
  • information on current and recent fraudulent prescription alerts;
  • examples of other prescription scams; and
  • a list of advice to clarify common misunderstandings that led to fraudulent prescriptions being dispensed.

The Stolen and forged prescriptions webpage provides details of practitioners whose names have been used on fraudulent prescriptions or stolen prescriptions that have been reported to MPR.

Pharmacists are encouraged to review the contents, visit the website regularly for updates and to bookmark the website for ease of reference.

Revocation of pharmacist’s approval following criminal conviction

A NSW pharmacist, who was found guilty of defrauding taxpayers more than $350,000 through falsely claiming benefits under the Pharmaceutical Benefits Scheme (PBS), has had their approval revoked by the Department of Health.

The revocation follows the pharmacist’s conviction by the New South Wales District Court on 12 March 2021 with an offence of engaging in a course of conduct with the intention of dishonestly obtaining a gain from the Commonwealth, contrary to section 135.1(1) of the Criminal Code Act 1995.

The revocation decision, which came into effect 8 April 2022, means the pharmacist ceased to be an approved pharmacist from that date and is no longer able to supply PBS medicines or receive payment from the Commonwealth for the supply of PBS medicines.

Details of the Department of Health and Aged Care’s decision can be found here.

Pharmacists’ Support Service

Pharmacists’ Support Service (PSS) is a free service run by pharmacists for pharmacists that is available 365 days a year from 8am to 11pm AEST on 1300 244 910.

The type of issues leading pharmacists to seek support from PSS include (but are not limited to) crime related trauma, workplace and workload concerns, employment matters, substance abuse, mental health issues, suicide, ill-health, difficulties arising from professional and financial pressures, practice matters and ethical issues. A common feature is stress.

There are also useful resources available on the PSS website that pharmacists may find helpful.

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 Standards and 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 R Cowie   (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

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Frequently Asked Questions