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Circular No. 27 - 16 December 2021

Circular No. 27 - 16 December 2021

In this Circular

  • Chair’s message
  • Special focus: Update on the draft Victorian Pharmacy Authority Standards
  • Regulatory Legislation Amendment (Reform) Bill 2021
  • Annual report
  • Quarterly performance report
  • Applications: Purchasers have omitted to lodge applications for licences

From the inspectors

  • Labelling of prepared syringes from multi-dose vials
  • Drug refrigerator temperature monitoring
  • Pharmacy security
For information

  • Ahpra registration renewal – implications of lapsed registration for owners
  • Office closure
  • Message from Western Victoria Primary Healthcare Network: Updating your organisation’s National Authentication Service for Health (NASH) certificate by March 2022

Resources

Chair's message

This circular includes an update on the Authority’s draft Standards following public consultation and meetings with stakeholders in recent months. The draft Standards reflect the requirements of the Pharmacy Regulation Act 2010 (the Act) in relation to the operation of Victorian pharmacies, pharmacy businesses and pharmacy departments and will be supported by the Victorian Pharmacy Authority Guidelines.

There is also information on the Regulatory Legislation Amendment (Reform) Bill 2021 and how it relates to the Act.

We remind proprietors to renew their Ahpra registration by 31 December given the significant implications of a lapsed registration on a licensee’s eligibility to hold a licence to carry on a pharmacy business.

An important message I would like to highlight is that pharmacists must ensure that an application for a pharmacy licence has been submitted to the Authority and that a licence has been granted prior to taking ownership of or commencing to carry on a pharmacy business. Failure to do so is a breach of the Act and may be subject to significant penalties.

The annual report and quarterly performance report are now available on the Authority's website.

On behalf of the Authority members and staff, I wish you a happy and safe festive season and best wishes for the new year.

 

David McConville
Chair

 

Special focus

Update on the draft Victorian Pharmacy Authority Standards

The Authority consulted with stakeholders on the draft Victorian Pharmacy Authority Standards (the draft Standards) in July 2021.

The draft Standards clarify mandatory requirements in relation to the operation of Victorian pharmacies, pharmacy businesses and pharmacy departments. In addition to the public consultation via the Authority’s website, industry peak bodies and key stakeholders were also approached for comment.

The draft Standards have been revised in response to the consultation feedback and the Authority plans to seek the Minister’s approval to issue the Standards in the coming weeks.

Regulatory Legislation Amendment (Reform) Bill 2021

The Regulatory Legislation Amendment (Reform) Bill 2021 was introduced to the Legislative Assembly on 29 November 2021. The Bill and the Explanatory Memorandum are available on the Victorian Legislation website. Part 14 of the Bill relates to the Act.

The Bill amends the Act to:

  • Provide for late renewals of licenses and registrations. Where a late renewal is renewed, it will be taken to have commenced on 1 July of the year in which the application for renewal is made. [There is currently no provision in the Act for late licence and registration renewals.]
  • Explicitly provide that inspections, panel hearings and meetings of the Victorian Pharmacy Authority can be conducted by means of an audio-visual link.

The Bill provides significant public benefit in that it enables the Authority to regulate as intended in the public interest, in a virtual environment when face to face settings may not be feasible or possible e.g., lock down provisions during a pandemic. The Bill also benefits licensees in that it removes risks associated with potentially operating a pharmacy unlawfully where renewal applications were not submitted in time and enables licensees who would otherwise need to travel large distances to attend panel hearings virtually.

A second reading of the Bill was moved on 1 December 2021. The Authority will keep stakeholders updated on the progress of the Bill in its communications.

Annual report

The Authority’s Annual Report 2020-21 was tabled in the Legislative Assembly on 18 November 2021 and is now available on the VPA website.

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 July 2021 to 30 September 2021 is available on the VPA website.

Applications

Purchasers have omitted to lodge applications for licences

There have been instances where purchasers of pharmacy businesses have omitted to lodge an application for a pharmacy business licence prior to taking ownership. Vendors may wish to check with the purchaser that an application has been submitted to the VPA for a pharmacy business licence to help avoid unnecessary delays in relation to the sale.

Pharmacists must not take ownership of or commence carrying on a pharmacy business until they have been granted a licence by the Authority. To do so is a breach of the Act and significant penalties apply.

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. 

Labelling of prepared doses from multi-dose vials

According to the Commonwealth COVID-19 Vaccination Training Program, if multiple doses are being made up at once, the container holding the syringes and each prepared syringe within the container must 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
  • Vial identifier (if available)

This is supported by the ATAGI site requirements for COVID-19 vaccination in community pharmacies which require pharmacies to develop policies and procedures for labelling syringes when they are drawn up from multi-dose vials.

Labelling of individual syringes 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. This risk is particularly significant in the current setting where pharmacies have access to three different COVID-19 vaccine brands.

Drug refrigerator temperature monitoring

VPA inspectors have observed cases where:

  • Manual minimum and maximum temperature monitoring of the drug refrigerator was not undertaken.
  • The drug refrigerator was not monitored using a temperature data logger, or the data logger was present but not functioning e.g., the battery had run out.

According to the National Vaccine Storage Guidelines 'Strive for 5', twice-daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in the cold chain. The data logger is used to continuously measure the refrigerator temperature at preset 5-minute intervals. A data logger is used in conjunction with manual monitoring to allow for the analysis and investigation of temperature deviations. The data should be downloaded at least weekly (and as soon as possible after a temperature breach is identified), reviewed and stored.

All pharmacists should be trained to operate and manage the data logger and interpret its readings. Pharmacies should have written procedures on cold chain management readily accessible by regular and locum pharmacists to support ongoing compliance.

For further information on cold chain management refer to the National Vaccine Storage Guidelines 'Strive for 5'.

Pharmacy security

Pharmacies and pharmacy departments are required to be substantially constructed and secured to prevent unauthorised access through doors, windows, skylights, walls and ceilings.

VPA inspectors have found several instances where the physical security of the pharmacy was inadequate, for example:

  • defective perimeter locks;
  • faulty electronic intruder alarm;
  • insufficient intrusion detectors installed to cover all areas where drugs are kept, including dispensary, drug safe, professional service area, storerooms and rooms used to store medicines for packing into dose administration aids;
  • perimeter doors to secluded or non-public areas not fitted with a substantial lock or not reinforced with heavy gauge metal sheeting or protected by a substantial metal security grilles or roller shutters; and
  • perimeter windows to secluded or non-public areas not fitted with bars or security grilles.

For information on pharmacy security, refer to VPA Guidelines 4.3.31 Security and Appendix 1 Security.

The self-audit form on the Authority’s website is a useful resource for licensees and pharmacists regularly and usually in charge to check that the physical security of the pharmacy complies with the Act and VPA guidelines. Identified pharmacy security issues should be addressed without delay.

For information

Ahpra registration renewal – implications of lapsed registration for owners

Registered pharmacists need to renew their Ahpra registration annually. According to the Pharmacy Board of Australia’s newsletter (Issue 31 – December 2021), pharmacists who do not apply to renew their registration with Ahpra by 31 December 2021 (end of late period) will have lapsed registration and will not be able to practise.

A pharmacist licensee whose registration lapses is no longer eligible to own or have a proprietary interest in a pharmacy business and the licence may be revoked. If the registration of a pharmacist director/shareholder of a company licensee lapses, the Authority may revoke the company licence.

Pharmacists are reminded to check their registration status and renew their registration as a matter of urgency. Pharmacists can check their registration details and expiry date on the national register of practitioners.

Office closure

The Authority’s office will close at 5.00pm on Thursday 23 December 2021 and re-open at 9:00am on Monday 10 January 2022.

Please note that any notifications (relating to change of ownership or commencement of a new pharmacy for example) submitted after 23 December will not be processed until 10 January 2022.

Updating your organisation’s National Authentication Service for Health (NASH) certificate by March 2022

Message from Western Victoria Primary Healthcare Network 

NASH certificates are used to:

  • Authenticate and securely access digital health services e.g. My Health Record, electronic prescribing etc.
  • Encrypt health information for secure exchange.
  • Digitally sign documents and other transactions.

A new version of the NASH certificate has been released and Western Victoria Primary Healthcare Network is supporting pharmacies in the transition to SHA-2 instead of the old SHA-1.

This change is to provide stronger protection and security.

Future digital health services will require the SHA-2 by 13th March 2022.

Suggested steps for updating the NASH certificate as well as helpful contact details are available 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 Guideline on compounding medicines here.
  • Pharmacy Board of Australia FAQ for pharmacists on the compounding of medicines here.
  • Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs 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 with reference to requirements for barcode scanning 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.
  • 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)
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: Update on the draft Victorian Pharmacy Authority Standards
  • Regulatory Legislation Amendment (Reform) Bill 2021
  • Annual report
  • Quarterly performance report
  • Applications: Purchasers have omitted to lodge applications for licences

From the inspectors

  • Labelling of prepared syringes from multi-dose vials
  • Drug refrigerator temperature monitoring
  • Pharmacy security
For information

  • Ahpra registration renewal – implications of lapsed registration for owners
  • Office closure
  • Message from Western Victoria Primary Healthcare Network: Updating your organisation’s National Authentication Service for Health (NASH) certificate by March 2022

Resources

Chair's message

This circular includes an update on the Authority’s draft Standards following public consultation and meetings with stakeholders in recent months. The draft Standards reflect the requirements of the Pharmacy Regulation Act 2010 (the Act) in relation to the operation of Victorian pharmacies, pharmacy businesses and pharmacy departments and will be supported by the Victorian Pharmacy Authority Guidelines.

There is also information on the Regulatory Legislation Amendment (Reform) Bill 2021 and how it relates to the Act.

We remind proprietors to renew their Ahpra registration by 31 December given the significant implications of a lapsed registration on a licensee’s eligibility to hold a licence to carry on a pharmacy business.

An important message I would like to highlight is that pharmacists must ensure that an application for a pharmacy licence has been submitted to the Authority and that a licence has been granted prior to taking ownership of or commencing to carry on a pharmacy business. Failure to do so is a breach of the Act and may be subject to significant penalties.

The annual report and quarterly performance report are now available on the Authority's website.

On behalf of the Authority members and staff, I wish you a happy and safe festive season and best wishes for the new year.

 

David McConville
Chair

 

Special focus

Update on the draft Victorian Pharmacy Authority Standards

The Authority consulted with stakeholders on the draft Victorian Pharmacy Authority Standards (the draft Standards) in July 2021.

The draft Standards clarify mandatory requirements in relation to the operation of Victorian pharmacies, pharmacy businesses and pharmacy departments. In addition to the public consultation via the Authority’s website, industry peak bodies and key stakeholders were also approached for comment.

The draft Standards have been revised in response to the consultation feedback and the Authority plans to seek the Minister’s approval to issue the Standards in the coming weeks.

Regulatory Legislation Amendment (Reform) Bill 2021

The Regulatory Legislation Amendment (Reform) Bill 2021 was introduced to the Legislative Assembly on 29 November 2021. The Bill and the Explanatory Memorandum are available on the Victorian Legislation website. Part 14 of the Bill relates to the Act.

The Bill amends the Act to:

  • Provide for late renewals of licenses and registrations. Where a late renewal is renewed, it will be taken to have commenced on 1 July of the year in which the application for renewal is made. [There is currently no provision in the Act for late licence and registration renewals.]
  • Explicitly provide that inspections, panel hearings and meetings of the Victorian Pharmacy Authority can be conducted by means of an audio-visual link.

The Bill provides significant public benefit in that it enables the Authority to regulate as intended in the public interest, in a virtual environment when face to face settings may not be feasible or possible e.g., lock down provisions during a pandemic. The Bill also benefits licensees in that it removes risks associated with potentially operating a pharmacy unlawfully where renewal applications were not submitted in time and enables licensees who would otherwise need to travel large distances to attend panel hearings virtually.

A second reading of the Bill was moved on 1 December 2021. The Authority will keep stakeholders updated on the progress of the Bill in its communications.

Annual report

The Authority’s Annual Report 2020-21 was tabled in the Legislative Assembly on 18 November 2021 and is now available on the VPA website.

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 July 2021 to 30 September 2021 is available on the VPA website.

Applications

Purchasers have omitted to lodge applications for licences

There have been instances where purchasers of pharmacy businesses have omitted to lodge an application for a pharmacy business licence prior to taking ownership. Vendors may wish to check with the purchaser that an application has been submitted to the VPA for a pharmacy business licence to help avoid unnecessary delays in relation to the sale.

Pharmacists must not take ownership of or commence carrying on a pharmacy business until they have been granted a licence by the Authority. To do so is a breach of the Act and significant penalties apply.

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. 

Labelling of prepared doses from multi-dose vials

According to the Commonwealth COVID-19 Vaccination Training Program, if multiple doses are being made up at once, the container holding the syringes and each prepared syringe within the container must 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
  • Vial identifier (if available)

This is supported by the ATAGI site requirements for COVID-19 vaccination in community pharmacies which require pharmacies to develop policies and procedures for labelling syringes when they are drawn up from multi-dose vials.

Labelling of individual syringes 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. This risk is particularly significant in the current setting where pharmacies have access to three different COVID-19 vaccine brands.

Drug refrigerator temperature monitoring

VPA inspectors have observed cases where:

  • Manual minimum and maximum temperature monitoring of the drug refrigerator was not undertaken.
  • The drug refrigerator was not monitored using a temperature data logger, or the data logger was present but not functioning e.g., the battery had run out.

According to the National Vaccine Storage Guidelines 'Strive for 5', twice-daily minimum and maximum temperatures must still be manually recorded as a timely alert to any breach in the cold chain. The data logger is used to continuously measure the refrigerator temperature at preset 5-minute intervals. A data logger is used in conjunction with manual monitoring to allow for the analysis and investigation of temperature deviations. The data should be downloaded at least weekly (and as soon as possible after a temperature breach is identified), reviewed and stored.

All pharmacists should be trained to operate and manage the data logger and interpret its readings. Pharmacies should have written procedures on cold chain management readily accessible by regular and locum pharmacists to support ongoing compliance.

For further information on cold chain management refer to the National Vaccine Storage Guidelines 'Strive for 5'.

Pharmacy security

Pharmacies and pharmacy departments are required to be substantially constructed and secured to prevent unauthorised access through doors, windows, skylights, walls and ceilings.

VPA inspectors have found several instances where the physical security of the pharmacy was inadequate, for example:

  • defective perimeter locks;
  • faulty electronic intruder alarm;
  • insufficient intrusion detectors installed to cover all areas where drugs are kept, including dispensary, drug safe, professional service area, storerooms and rooms used to store medicines for packing into dose administration aids;
  • perimeter doors to secluded or non-public areas not fitted with a substantial lock or not reinforced with heavy gauge metal sheeting or protected by a substantial metal security grilles or roller shutters; and
  • perimeter windows to secluded or non-public areas not fitted with bars or security grilles.

For information on pharmacy security, refer to VPA Guidelines 4.3.31 Security and Appendix 1 Security.

The self-audit form on the Authority’s website is a useful resource for licensees and pharmacists regularly and usually in charge to check that the physical security of the pharmacy complies with the Act and VPA guidelines. Identified pharmacy security issues should be addressed without delay.

For information

Ahpra registration renewal – implications of lapsed registration for owners

Registered pharmacists need to renew their Ahpra registration annually. According to the Pharmacy Board of Australia’s newsletter (Issue 31 – December 2021), pharmacists who do not apply to renew their registration with Ahpra by 31 December 2021 (end of late period) will have lapsed registration and will not be able to practise.

A pharmacist licensee whose registration lapses is no longer eligible to own or have a proprietary interest in a pharmacy business and the licence may be revoked. If the registration of a pharmacist director/shareholder of a company licensee lapses, the Authority may revoke the company licence.

Pharmacists are reminded to check their registration status and renew their registration as a matter of urgency. Pharmacists can check their registration details and expiry date on the national register of practitioners.

Office closure

The Authority’s office will close at 5.00pm on Thursday 23 December 2021 and re-open at 9:00am on Monday 10 January 2022.

Please note that any notifications (relating to change of ownership or commencement of a new pharmacy for example) submitted after 23 December will not be processed until 10 January 2022.

Updating your organisation’s National Authentication Service for Health (NASH) certificate by March 2022

Message from Western Victoria Primary Healthcare Network 

NASH certificates are used to:

  • Authenticate and securely access digital health services e.g. My Health Record, electronic prescribing etc.
  • Encrypt health information for secure exchange.
  • Digitally sign documents and other transactions.

A new version of the NASH certificate has been released and Western Victoria Primary Healthcare Network is supporting pharmacies in the transition to SHA-2 instead of the old SHA-1.

This change is to provide stronger protection and security.

Future digital health services will require the SHA-2 by 13th March 2022.

Suggested steps for updating the NASH certificate as well as helpful contact details are available 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 Guideline on compounding medicines here.
  • Pharmacy Board of Australia FAQ for pharmacists on the compounding of medicines here.
  • Therapeutic Goods Administrations GMP information for manufacturers of compounded medicines and DAAs 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 with reference to requirements for barcode scanning 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.
  • 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)
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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